Atlas FDA

LJT

288 FDA 510(k) clearances · Product code

96 daysmedian time to decision
286 days90th percentile
288clearances measured

FDA profile

Official device name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5965
Medical specialty
General Hospital
Flags
Implant
Adverse events (MAUDE)
2021: 1,285 · 2022: 1,334 · 2023: 1,221 · 2024: 1,896 · 2025: 4,363 · 2026: 2,390
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
FLEXI-PORT™ Power Injectable Implantable Port (K260916)Portal Access, Inc.2026-06-17
Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port (K252478)Bard Access Systems, Inc.2025-09-05
PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port (K251253)Bard Access Systems, Inc.2025-06-18
PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports (K242328)Bard Access Systems, Inc.2024-10-31
PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port (K232737)Bard Peripheral Vascular, Inc.2023-12-08
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports (K190559)AngioDynamics, Inc.2020-05-22
Bard Power-Injectable Implantable Ports (PowerPorts®) (K181446)C.R. Bard, Inc.2019-07-08
NMI DUAL PORT II (K151239)Navilyst Medical, Inc.2016-06-06
BardPort®, SlimPort®, and X-Port® Implanted Ports (K153359)C.R. Bard, Inc.2016-05-20
Dignity Dual Port (K153238)Medcomp ( Medical Components)2016-03-15
NMI Port, NMI Port II (K153228)Navilyst Medical, Inc.2015-12-04
Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters (K150514)C.R. Bard, Inc.2015-11-20
Vital-Port Vascular Access System Power Injectable Port (K150733)Cook Incorporated2015-05-21
INVISIPORT (K141146)Stealth Therapeutics, Incorporated2015-05-01
VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM (K140169)Cook Incorporated2014-05-21
POWERPORT IMPLANTABLE PORT (K133335)C.R. Bard, Inc.2014-02-14
MEDCOMP GEN III POWER INJECTABLE PORT (K132177)Medcomp ( Medical Components)2013-12-12
POLYSITE IMPLANTABLE INFUSION PORTS (K122834)Perouse Medical2013-12-11
NMI PORT II CATHETER (K131694)Navilyst Medical, Inc.2013-08-08
5F DIGNITY CT TITANIUM PORT (K130923)Medical Components, Inc.2013-07-31
LPP (LOW PROFILE PORT) (K122402)Pfm Medical, Inc.2013-07-16
NMI PORT (K122767)Navilyst Medical, Inc.2013-04-30
CELSITE IMPLANTABLE ACCESS PORT SYSTEMS (K130576)B. Braun Interventional Systems, Inc.2013-04-02
POWERPORT CLEARVUE SLIM IMPLANTABLE PORT (K122899)C.R. Bard, Inc.2012-11-15
DIGNITY POWER INJECTABLE TITANIUM PORT (K120281)Medical Components, Inc.2012-09-17
DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL (K110424)Medcomp ( Medical Components)2011-11-30
NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS (K112713)Norfolk Medical Products, Inc.2011-10-27
INVISIPORT (K110407)Stealth Therapeutics, Incorporated2011-10-13
NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET (K111101)Norfolk Medical2011-08-25
NORFOLK MEDICAL NORPORT FAMILY OF PORTS (K102385)Norfolk Medical Products, Inc.2011-01-14
ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS (K101017)AngioDynamics, Inc.2010-06-17
PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS (K093414)Smiths Medical Asd, Inc.2010-03-01
C-PORT - HP POWER INJECTABLE PORT (K091099)Phs Medical GmbH2009-05-22
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER (K090512)C.R. Bard, Inc.2009-03-27
RHAPSODY MRI (K082126)Grantadler Corporation2008-11-13
RHAPSODY CT (K081889)Grantadler Corporation2008-11-12
COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT (K081425)Cook Vascular, Inc.2008-09-30
SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS (K081472)AngioDynamics, Inc.2008-09-23
POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER (K081311)C.R. Bard, Inc.2008-06-04
STD MED PRIMO PORT POLY (K080645)Std Med, Inc.2008-05-02
JET PORT PLUS HP CATHETER SYSTEM (K072481)Pfm Medical, Inc.2008-03-07
MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER (K073423)C.R. Bard, Inc.2007-12-19
POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS (K072657)Smiths Medical MD, Inc.2007-12-14
MODIFICATION TO: T-PORT HP INFUSION PORT (K073210)Pfm Medical, Inc.2007-12-12
TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER (K072549)C.R. Bard, Inc.2007-11-14
TITANIUM POWERPORT ISP IMPLANTED PORT (K072215)C.R. Bard, Inc.2007-11-01
T-PORT HP INFUSION PORT (K071993)Pfm Medical, Inc.2007-10-17
STD MED PRIMO PORT (K070911)Std Med, Inc.2007-08-10
POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE (K070116)Smiths Medical MD, Inc.2007-05-23
POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) (K070003)Medcomp2007-05-15
VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET (K062414)Rita Medical Systems, Inc.2007-02-01
POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER (K063377)C.R. Bard, Inc.2007-01-25
CELSITE/ CELSITE CONCEPT, ACCESS PORTS (K061424)Aesculap, Inc.2006-07-31
POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE (K060812)C.R. Bard, Inc.2006-07-14
PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER (K060036)Smiths Medical MD, Inc.2006-05-17
GRANTALDER RHAPSODY ACCESS PORT AND CATHETER (K043178)Grantadler Corportation2006-02-02
BARDPORT TITANIUM PORTS (K050310)Bard Access Systems, Inc.2005-04-18
VORTEX EZ VASCULAR ACCESS PORT (K050176)Rita Medical Systems, Inc.2005-02-25
PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM (K033686)Smiths Medical MD, Inc.2004-01-23
MODIFICATION TO X-PORT DUO PORT (K034065)C.R. Bard, Inc.2004-01-15
MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT (K033473)Horizon Medical Products, Inc.2003-11-18
VORTEX MP (K032754)Horizon Medical Products, Inc.2003-09-12
VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233 (K032600)Boston Scientific Corp2003-09-09
TRIUMPH VTX WITH LIFEVALVE CATHETER (K032557)Horizon Medical Products, Inc.2003-09-09
VAXCEL PORT, MODELS 45-336 AND 45-338 (K032375)Boston Scientific Corp2003-08-19
OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05 (K031282)LeMaitre Vascular, Inc.2003-08-05
VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 (K031844)Boston Scientific Corp2003-07-15
VAXCEL WITH PASV PORT, MODEL 45-213 (K032008)Boston Scientific Corp2003-07-14
X-PROT DUO PORT (K032044)C.R. Bard, Inc.2003-07-10
C-PORT (K030636)Clinisurg Vascular Products, LLC2003-06-05
OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05 (K021580)LeMaitre Vascular, Inc.2003-02-12
VAXCEL WITH PASV PORT (K030083)Boston Scientific Corp2003-01-28
BARDPORT X-PORT ISP PORT (K022983)C.R. Bard, Inc.2002-09-25
KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. (K022110)Kawasumi Laboratories, Inc.2002-09-12
LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES (K010767)Horizon Medical Products, Inc.2001-04-10
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER (K010426)Sims Deltec, Inc.2001-03-08
VORTEX ACCESS SYSTEM (K010189)Horizon Medical Products, Inc.2001-02-12
TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION (K003006)Arrow Intl., Inc.2000-10-27
IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 (K002770)Hdc Corp.2000-09-26
JET PORT PLUS CATHETER SYSTEM (K000125)Clinical Plastic Products SA2000-04-12
CELSITE IMPLANTABLE PORT WITH VALVED CATHETER (K993024)B. Braun of America, Inc.2000-03-13
HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM (K994196)Horizon Medical Products, Inc.2000-02-10
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM (K994216)Sims Deltec, Inc.2000-01-27
CELSITE, MODELS ST401L, ST405L (K994111)B. Braun/Mcgaw2000-01-03
CATHETER INNOVATIONS IMPLANTABLE PORT (K993860)Catheter Innovations, Inc.1999-12-03
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM (K992697)Sims Deltec, Inc.1999-11-18
CATHETER INNOVATIONS IMPLANTABLE PORT (K991897)Catheter Innovations, Inc.1999-10-21
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM (K992880)Sims Deltec, Inc.1999-10-19
BPOS-IVAD STABILIZER (K983480)Bpos, Inc.1998-11-23
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM (K982888)Boston Scientific Corp1998-10-20
MINI POLYURETHANE CATHETER (K982507)Med Institute, Inc.1998-09-16
TRIMPORT (K974533)Gerard Medical, Inc.1998-05-07
THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 (K974475)Biocontrol Technology, Inc.1998-03-02
NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) (K974829)Kawasumi Laboratories Co., Ltd.1998-02-12
PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A (K974471)Sims Deltec, Inc.1998-01-22
HUBERLOC (K973497)Medcare Medical Group, Inc.1998-01-13
PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS (K973862)Sims Deltec, Inc.1997-12-29
NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET (K971582)Nipro Medical Corp.1997-12-22
VITAL-PORT INFUSION PAL (K971140)Med Institute, Inc.1997-11-17
TARGET VITAL-PORT VASCULAR ACCESS SYSTEM (K970442)Med Institute, Inc.1997-04-30
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