Atlas FDA

MSD

124 FDA 510(k) clearances · Product code

105 daysmedian time to decision
273 days90th percentile
124clearances measured

FDA profile

Official device name
Catheter, Hemodialysis, Implanted
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5540
Medical specialty
Gastroenterology, Urology
Flags
Implant · Life-sustaining
Adverse events (MAUDE)
2021: 523 · 2022: 610 · 2023: 542 · 2024: 841 · 2025: 1,071 · 2026: 569
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Hemodialysis Catheter (K241581)Haolang Medical USA Corporation2025-05-16
End Cap (K210461)Medical Components Inc (Medcomp)2021-09-14
GlidePath Retro Long-Term Hemodialysis Catheter (K203575)C.R. Bard, Inc.2021-07-01
GlidePath 13F Long-Term Hemodialysis Catheter (K211410)Bard Peripheral Vascular, Inc.2021-06-04
Pristine Long-Term Hemodialysis Catheter (K203767)C B Bard, Inc.2021-04-02
GlidePath 7.5F Long-Term Dialysis Catheter (K202150)C.R. Bard, Inc.2020-11-18
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes (K202176)Medical Components, Inc. (dba MedComp)2020-09-03
GlidePath 10F Long-Term Dialysis Catheter (K200627)C.R. Bard, Inc.2020-06-22
GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters (K190527)C. R. Bard2020-03-05
Pristine Hemodialysis Catheter (K182443)Pristine Access Technologies , Ltd.2019-05-31
15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes (K173667)Medical Components, Inc. (dba MedComp)2018-05-17
NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm) (K173805)Marvao Medical Devices, Ltd.2018-02-08
NexSite HD, Hemodialysis Step Tip Catheter (60cm) (K171571)Marvao Medical Devices, Ltd.2017-11-30
Symetrex Long Term Hemodialysis Catheter (K171618)Medcomp (Dba Medical Components, Inc.)2017-11-16
NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) (K161026)Marvao Medical Devices, Ltd.2016-08-09
Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter (K151967)Merit Medical Systems, Inc.2016-04-04
NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm) (K143567)Marvao Medical Devices, Ltd.2015-03-31
SYMETREX LONG TERM HEMODIALYSIS CATHETER (K140884)Phase One Medical2014-11-26
NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE (K140492)Marvao Medical Devices, Ltd.2014-11-13
VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU (K141051)Arrow International, Inc.2014-07-07
CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER (K141363)Merit Medical Systems, Inc.2014-06-18
SPLIT CATH RG (K130889)Medcomp2014-04-28
NMI DIALYSIS CATHETER (K131260)Navilyst Medical, Inc.2014-02-14
NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM), (K133796)Marvao Medical Devices, Ltd.2014-01-31
CASCADE HEMODIALYSIS/APHERESIS CATHETER (K130851)Health Line International Corporation2014-01-09
AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER (K131814)Ameco Medical Industries2013-07-26
NEXTSTEP RETROGRADE (K130192)Arrow International, Inc.2013-05-10
AMECATH DUAL LUMEN HEMODIALYSIS CATHETER (K123943)Ameco Medical Industries2013-04-02
NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM) (K121933)Marvao Medical Devices, Ltd.2013-03-14
PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH (K123196)Covidien2013-01-31
SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM (K121848)Medical Components, Inc.2012-09-21
HEMO-CATH 10F, HEMO-CATH 12.5F (K113487)Medical Components, Inc.2012-03-09
SPLIT CATH III (K111651)Medical Components, Inc.2011-12-08
PALINDROME RT CHRONIC CATHETER (K111817)Covidien2011-08-30
NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER (K111900)Teleflexmedical, Inc.2011-08-17
TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... (K111372)Covidien2011-08-04
CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... (K111117)Teleflexmedical, Inc.2011-06-30
DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT (K110936)AngioDynamics, Inc.2011-06-10
ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER (K102238)Teleflexmedical, Inc.2011-02-01
ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER (K102043)Rex Medical2010-11-18
DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT (K101843)AngioDynamics, Inc.2010-10-20
DURASPAN HEMODIALYSIS LONG-TERM CATHETER (K100169)R4 Vascular, Inc.2010-02-18
DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 (K091506)R4 Vascular, Inc.2010-01-08
CENTROS CHRONIC HEMODIALYSIS CATHETER SET (K092597)Ash Access Technology, Inc.2009-11-12
PALINDROME P HEMODIALYSIS CATHETER (K092205)Covidien Lp, Formerly Registered AS Kendall2009-10-30
DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) (K091760)Dermaport, Inc.2009-07-20
DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT (K090528)C.R. Bard, Inc.2009-05-28
PROGUIDE CHRONIC DIALYSIS CATHETER (K090148)Merit Medical Systems, Inc.2009-04-13
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS (K090101)C.R. Bard, Inc.2009-02-10
ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT (K080400)AngioDynamics, Inc.2008-05-13
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, (K073092)Spire Biomedical, Inc.2008-01-29
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, (K073093)Spire Biomedical, Inc.2008-01-22
DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS) (K071202)Dermaport, Inc.2007-11-30
NOVOFLO CATHETER LT (K072499)Novosci, Inc.2007-10-30
15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET (K071422)Rex Medical2007-08-22
ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM (K070572)Ash Access Technology, Inc.2007-06-26
15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 (K063441)Spire Biomedical, Inc.2007-02-12
HEMOCATH II (K062901)Med-Conduit, Inc.2007-02-08
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 (K063431)Spire Biomedical, Inc.2007-01-29
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) (K062671)Kendall2006-11-03
RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS (K060288)Spire Biomedical, Inc.2006-09-01
KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) (K060972)Kendall2006-08-04
15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (K060155)Spire Biomedical, Inc.2006-05-09
LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING (K053589)Bard Access Systems, Inc.2006-04-13
MEDCOMP SPLIT CATH II (K051280)Medcomp2005-11-30
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY (K051584)Kendall2005-10-06
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS (K051748)C.R. Bard, Inc.2005-08-12
14F DUAL FLOATING DIALYSIS CATHETER/TRAY (K042672)Cardio Med Supplies, Inc.2005-03-23
HEMOCATH (K043292)Med-Conduit, Inc.2005-03-16
MEDCOMP SPLIT-CATH II (K040318)Medcomp2005-02-03
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP (K043272)Kendall2004-12-22
55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS (K042858)Spire Biomedical, Inc.2004-12-03
15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER (K040328)Medcomp2004-11-24
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER (K041914)Kendall2004-09-27
DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER (K042016)Datascope Corp.2004-09-23
55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 (K041559)Spire Biomedical, Inc.2004-07-30
15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706 (K040992)Medcomp2004-07-29
TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR (K041006)Kendall2004-05-19
VAXCEL PLUS CHRONIC DIALYSIS CATHETER (K040736)Boston Scientific Corp2004-05-18
STEP-TIP CHRONIC HEMODIALYSIS CATHETER (K040666)Arrow International, Inc.2004-05-14
ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT (K040402)AngioDynamics, Inc.2004-04-19
ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 (K040509)Spire Biomedical, Inc.2004-04-19
VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER (K040492)Boston Scientific Corp2004-03-16
INTEGRAL HEMODIALYSIS CATHETER (K040260)Arrow Int'L.2004-03-05
PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER (K033676)Kendall2004-02-20
CANNON II PLUS (K040078)Arrow International, Inc.2004-02-13
DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH (K032061)Spire Biomedical, Inc.2003-12-23
LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA (K023023)Vasca, Inc.2003-12-04
HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER (K033294)C.R. Bard, Inc.2003-11-26
VAXCEL PLUS CHRONIC DIALYSIS CATHETER (K032712)Boston Scientific Corp2003-10-02
SOFT-CELL DUAL LUMEN CATHETERS (K030277)C.R. Bard, Inc.2003-08-06
HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER (K030020)C.R. Bard, Inc.2003-06-16
14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 (K030502)Medcomp2003-05-20
DIATEK CANNON-CATHETER, MODEL CC5500 (K022662)Arrow Intl., Inc.2003-05-09
HEMO-STREAM HEMODIALYSIS CATHETER SET (K023847)Rex Medical2003-04-30
TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY (K030983)Deltec, Inc.2003-04-25
MEDCOMP SC4 (K022678)Medcomp2003-02-24
LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER (K022905)Horizon Medical Products, Inc.2002-12-13
10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL (K020936)Medcomp2002-10-11
14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55 (K021759)Medcomp2002-08-27
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Every clearance here is in the API, with alerts when new ones post.