Atlas FDA

LJS

302 FDA 510(k) clearances · Product code

90 daysmedian time to decision
291 days90th percentile
302clearances measured

FDA profile

Official device name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5970
Medical specialty
General Hospital
Flags
Implant
Adverse events (MAUDE)
2021: 3,084 · 2022: 3,256 · 2023: 2,799 · 2024: 4,243 · 2025: 4,424 · 2026: 1,891
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
Neonav ECG Tip Location System (K260929)Navi Medical Technologies2026-04-17
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology (K252373)Spectrum Vascular2025-12-16
PM2™ System with ECGuide™ Connector (K252792)Piccolo Medical, Inc.2025-11-17
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr (K243458)Access Vascular, Inc.2025-08-01
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) (K251212)Access Vascular, Inc.2025-07-01
PM2+ System and SmartPICC Stylet (K243484)Piccolo Medical, Inc.2025-05-29
pilot TLS (K241587)Vygon Corporation2025-02-26
Neonav ECG Tip Location System (K241910)Navi Medical Technologies2025-01-19
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) (K243941)Access Vascular, Inc.2025-01-17
PM2 System and ECGuide Connector (K240486)Piccolo Medical, Inc.2024-09-08
CATHTONG III Tapered PICC Catheter (K233149)L&Z Us, Inc.2023-12-01
L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters (K230669)Argon Medical Devices2023-11-30
CATHTONG™ II PICC Catheter (K232571)L&Z Us, Inc.2023-09-22
CATHTONG™ II PICC Catheter (K232594)L&Z Us, Inc.2023-09-22
Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly (K222232)Bard Access Systems, Inc.2022-08-24
VPS Rhythm DLX Device with TipTracker Technology (K220363)Arrow International, LLC (A subsidiary of Teleflex, Inc.)2022-08-22
HydroPICC 5F Dual Lumen Catheter (K213550)Access Vascular, Inc.2022-05-04
BD PowerPiCC Catheter (K210264)Bard Access Systems, Inc.2021-07-30
Groshong NXT PICC Catheter (K201452)C.R. Bard, Inc.2021-03-12
Piccolo Medical SmartPICC System (K200037)Piccolo Medical, Inc.2021-01-22
Biowy PICC Catheter S Kit (K192246)Biowy Corporation2020-04-30
HydroPICC (PICC-142) (K193015)Access Vascular, Inc.2020-02-20
Jet Power Injectable PICC (K180546)Jet Medical, Inc.2018-11-21
5 FR Dual Lumen Piper PICC (K181904)Piper Access, LLC2018-09-25
Sherlock 3CG+ T ip Confirmation System (K180560)C.R. Bard, Inc.2018-06-18
Biowy PlCC Catheter (K173956)Biowy Corporation2018-05-21
3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology (K180548)C.R. Bard, Inc (Bard Has Joined Bd)2018-04-26
Hickman TriFusion Catheter (K172511)C.R. Bard, Inc.2018-04-20
C3 Wave System (K180567)Medical Components, Inc. (dba MedComp)2018-04-12
Vygon PICCs (K172899)Vygon USA2018-02-26
Silicone Peripherally Inserted Central Venous Catheter Set/Tray (K171994)Cook Incorporated2018-02-22
HydroPICC (K172885)Access Vascular, Inc.2018-02-20
C3 Wave System (K170934)Medical Components, Inc (Dba Medcomp_2017-12-06
Celerity ECG Cable Accessory Pack (K171931)Medcomp (Medical Components, Inc.)2017-10-26
Sherlock 3CG Tip Positioning System Stylet (K172397)C.R. Bard, Inc.2017-09-29
CATHTONG II PICC Catheter (K172039)L&Z Us, Inc.2017-08-03
CATHTONG II PICC Catheter (K170486)L&Z Us, Inc.2017-05-25
PowerPICC Provena Catheters with SOLO Valve Technology (K162441)C.R. Bard, Inc.2017-04-24
PICC Maximal Barrier Nursing Kit (K163452)Navilyst Medical, Inc.2017-02-03
VPS Rhythm Device with TipTracker Technology (K160925)Arrow International, Inc. (A Subsidiary of Teleflex, Inc.)2016-12-22
PowerPICC Provena Catheters (K162443)C.R. Bard, Inc.2016-10-25
Turbo-Flo PICC Sets (K161496)Cook Incorporated2016-10-07
CG+ Arrow JACC (K161765)Arrow International, Inc. (Subsidiary of Teleflex2016-09-06
Cathtong I PICC Catheter (K153469)L&Z Us, Inc.2016-09-01
PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter (K151985)C.R. Bard, Inc.2016-06-14
Amecath Peripheral inserted Central Venous Catheter Sets (K152819)Ameco Medical Industries2016-02-05
CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS (K153487)Arrow International, Inc. (Subsidiary of Teleflex, Inc.)2016-02-04
CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC (K153423)Arrow International, Inc. (Subsidiary of Teleflex, Inc.)2016-01-28
PICC Tip Positioning Aid (K152261)Nostix, LLC2015-10-21
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC (K152409)Navilyst Medical, Inc.2015-09-24
C3 Wave (K143238)Medcomp ( Medical Components)2015-04-24
Xcela Power Injectable PICC (K150527)Navilyst Medical, Inc.2015-03-31
NMI PICC III and NMI PICC IV (K150448)Navilyst Medical, Inc.2015-03-19
Celerity PICC Tip Confirmation System (K142889)AngioDynamics, Inc.2015-01-27
NAUTILUS DELTA (K141634)Romedex International Srl2015-01-27
Sherlock 3CG Tip Positioning System Stylet (K142267)C.R. Bard, Inc.2014-10-17
PICC Maximal Barrier Nursing Kit (K142616)Navilyst Medical, Inc.2014-10-14
PRO-PICC WITH VALVE TECHNOLOGY (K141633)Medical Components, Inc.2014-09-29
TURBO-JECT PICC SETS (K141818)Cook Corporated2014-08-05
CT MIDLINE (K141151)Medcomp (Medical Components, Inc.)2014-07-08
CELERITY SYSYEM (K140799)Medcomp (Medical Components, Inc.)2014-06-13
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) (K140345)C.R. Bard, Inc.2014-03-14
NMI PICC IV (K140266)Navilyst Medical, Inc.2014-03-05
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET (K133634)Cook, Inc.2013-12-23
NMI PICC III (K133264)Navilyst Medical, Inc.2013-11-20
ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN (K132567)Covidien2013-11-05
MEDCOMP VASCU-PICC WITH VALVE (K130897)Medcomp ( Medical Components)2013-10-22
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET (K132885)Cook Incorporated2013-10-11
6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET (K131687)Medical Components, Inc.2013-08-16
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET (K132334)Cook, Inc.2013-08-16
NMI PICC III CATHETER, NMI HPICC III CATHETER (K131942)Navilyst Medical, Inc.2013-07-31
FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER (K130507)Footprint Medical, Inc.2013-06-03
3F PRO-PICC (K123617)Medical Components, Inc.2013-05-15
NMI PICC MAXIMAL BARRIER NURSING KITS (K131038)Navilyst Medical, Inc.2013-05-09
CG+ ARROW PICC POWERED BY ARROW VPS STYLET (K130876)Arrow International, Inc.2013-04-26
UNI-PICC (K130034)Health Line International Corporation2013-03-08
CG+ ARROW PICC POWERED BY ARROW VPS STYLET (K123759)Arrow International, Inc. (Subsidiary of Teleflex2013-01-03
VASU-PICC (K122423)Medical Components, Inc.2012-12-12
ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) (K121501)Arrow International (Subsidiary of Teleflex Inc.)2012-11-29
NYLUS PICC (K113225)Semprus Biosciences2012-11-06
NMI HPICC III (K122882)Navilyst Medical, Inc.2012-10-18
CG+ ARROW PICC POWERED BY ARROW VPS STYLET (K122545)Arrow International (Subsidiary of Teleflex Inc.)2012-09-20
ARROW PICC POWERED BY ARROW VPS STYLET (K121941)Arrow International (Subsidiary of Teleflex Inc.)2012-09-07
NMI PICC III (K121089)Navilyst Medical, Inc.2012-08-23
PICC CONVENIENCE KIT (K121990)Navilyst Medical, Inc.2012-08-03
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS (K113277)Arrow International, Inc.2012-06-21
MEDCOMP VASCU-PICC & MIDLINE CATHETERS (K121094)Medical Components, Inc.2012-06-06
ARRW EVOLUTION (K112896)Arrow International (Subsidiary of Teleflex Inc.)2012-05-10
2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC (K120981)Medical Components, Inc.2012-05-02
1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC (K120980)Medical Components, Inc.2012-05-02
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) (K113808)C.R. Bard, Inc.2012-03-19
DIRECT ANTIBIOTIC INFUSION KIT (K113043)Summit Medical Products, Inc.2011-12-20
SAPIENS TIP CONFIRMATION SYSTEM (K112744)C.R. Bard, Inc.2011-10-20
TRIPLE LUMEN PFM PICC (K110914)Pfm Medical, Inc.2011-09-21
NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER (K110627)Marvao Medical Devices, Ltd.2011-08-12
XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY (K111906)Navilyst Medical, Inc.2011-07-29
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) (K111244)Cook, Inc.2011-06-14
2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC (K102966)Medcomp2010-12-21
POWERPICC SV CATHETERS (K102159)C.R. Bard, Inc.2010-11-17
NMI IC (K101326)Navilyst Medical, Inc.2010-09-02
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