Atlas FDA

LFJ

65 FDA 510(k) clearances · Product code

78 daysmedian time to decision
428 days90th percentile
65clearances measured

FDA profile

Official device name
Catheter, Subclavian
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5540
Medical specialty
Gastroenterology, Urology
Flags
Implant
Adverse events (MAUDE)
2021: 37 · 2022: 34 · 2023: 44 · 2024: 48 · 2025: 28 · 2026: 15
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
MEDSURG INSERTION TRAY (K920780)Medsurg Industries, Inc.1994-08-19
AKCESS0CATH KIT (K925819)Akcess Medical Products, Inc.1994-08-02
AKCESS-CATH (K925818)Akcess Medical Products, Inc.1994-04-05
ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY (K913468)Cook, Inc.1994-03-24
COAXIAL ACUTE CATHETER (K931120)Akcess Medical Products, Inc.1994-01-14
SPLITTABLE SHEATH INTRODUCER SET (K920634)Akcess Medical Products, Inc.1994-01-14
VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS (K914162)Vas-Cath, Inc.1993-07-01
HEMO-CATH SILICONE ACCESS CATHETER (K915423)Medical Components, Inc.1993-02-02
AKCESS-CATH KIT (K914826)Akcess Medical Products, Inc.1992-04-10
PERMANENT SILICONE CATHETERS (K910501)Akcess Medical Products, Inc.1991-04-29
MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER (K905080)Kendall Healthcare Products Co. Div.Of Tyco Health1991-01-31
SINGLE LUMEN CATHETER KITS (K904139)Akcess Medical Products, Inc.1990-12-04
SINGLE LUMEN CATHETERS, MODIFICATION (K904140)Akcess Medical Products, Inc.1990-11-27
DURACATH (K901133)Impra, Inc.1990-06-08
SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000 (K901061)Akcess Medical Products, Inc.1990-05-22
MODIFIED PERM-CATH (K900835)Quinton, Inc.1990-05-09
DUALYSE-CATH - CODES #1132.212, 1132.112 (K896568)Vygon Corp.1990-05-09
DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S (K900803)Akcess Medical Products, Inc.1990-04-25
FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER (K895506)Vas-Cath, Inc.1990-02-09
ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT (K895417)Arrow Intl., Inc.1990-01-03
HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C (K893439)Medical Components, Inc.1989-06-13
DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800 (K891753)Akcess Medical Products, Inc.1989-06-08
DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K (K891755)Akcess Medical Products, Inc.1989-06-08
SUBCLAVIAN HEMODIALYSIS CATHETER (K884322)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-04-25
HEMO-CATH SILICONE DOUBLE LUMEN CATHETER (K890029)Medical Components, Inc.1989-04-17
MODIFIED VAS-CATH CATHETER REPAIR KIT (K890099)Vas-Cath, Inc.1989-04-11
IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER (K883592)Impra, Inc.1988-12-08
VAS-CATH CATHETER REPAIR KIT (K883768)Vas-Cath, Inc.1988-11-14
MEDSURG ACUTE DIALYSIS TRAY (K880778)Medsurg Industries, Inc.1988-07-15
DESERET SUBCLAVIAN HEMODIALYSIS CATHETER (K881695)Deseret Medical, Inc.1988-06-23
VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER (K881743)Vas-Cath, Inc.1988-06-23
MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA (K881290)Shiley, Inc.1988-04-27
LUER LOCK CONNECTORS / RIDIG P.V.C. (K875188)Vas-Cath of Canada , Ltd.1988-03-02
PERMCATH INSERTION TRAY (K874633)Quinton, Inc.1988-02-17
ADULT PERM-CATH 40CM. (K871749)Quinton, Inc.1987-06-17
PERM-CATH CATHETER KIT (K871942)Quinton, Inc.1987-06-17
VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH (K871488)Vas-Cath of Canada , Ltd.1987-06-12
VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH (K871487)Vas-Cath of Canada , Ltd.1987-06-12
SINGLE LUMEN ACUTE CATHETER (K870328)Quinton, Inc.1987-05-11
MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA (K863697)Shiley, Inc.1986-10-02
SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA (K861174)Shiley, Inc.1986-04-23
HURWITZ DIALYSIS CATHETER (K860094)Gish Biomedical, Inc.1986-04-07
VACCESS TM 4006 (K853283)Vas-Cath of Canada , Ltd.1985-08-22
SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL (K852070)Shiley, Inc.1985-06-13
MNI 400 INJECTION CAPS (K852162)Med-West, Inc.1985-06-12
VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH (K844336)Vas-Cath of Canada , Ltd.1985-03-13
VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH (K844434)Vas-Cath of Canada , Ltd.1985-03-13
VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA (K844433)Vas-Cath of Canada , Ltd.1985-03-13
SINGLE LUMEN SUBCLAVIAN CANNULA (K840197)Shiley, Inc.1984-04-25
DUAL LUMEN SUBCLAVIAN CANNULA (K833848)Shiley, Inc.1983-12-08
MCDLSCK 126 DOUBLE LUMEN SUBCLAVIAN-FEM (K830438)Medcomp1983-03-17
DOUBLE LUMEN SUBCLAVIAN CATHETER (K823135)Abbott Laboratories1983-03-07
RIGHT ATRIAL CATHETER (K822964)Quinton, Inc.1982-11-30
RIGHT ARTERIAL CATHETER (K822910)Quinton, Inc.1982-11-29
SHIELY DUEL LUMEN SUBCLAVIAN CANNULA (K822134)Shiley, Inc.1982-08-03
MCPARLAND SCALP VEIN CATHETER (K821001)Renal Systems, Inc.1982-07-22
MCSCK638 CATHETER IN A TRAY (KIT) (K821955)Medcomp1982-07-14
MCSCK838 CATHETER IN A TRAY (KIT) (K821954)Medcomp1982-07-14
MCSCP8PS WITH 'Y' HUB (K821684)Medical Components, Inc.1982-06-24
MAHURKAR SUBCLAVIAN CATHETER (K821400)Quinton, Inc.1982-06-23
H-H ALIMENTATION CATHETERS (K821012)Holter-Hausner Intl.1982-05-28
COBE ACUFLEX SSN, #15-220 (K820238)Cobe Laboratories, Inc.1982-03-10
SORENSON SUBCLAVIAN CATHETER SSC-8 (K812326)Sorensen Research1981-09-25
DOUBLE LUMEN SUBCLAVIN CATHETER SC-400 (K810745)Vas-Cath of Canada , Ltd.1981-03-31
MEDCOMP SUBCLAVIAN CATHETER (K801672)Medical Components, Inc.1980-12-18

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