ClearanceBrief
Panels › General Hospital › Product code LJS · Class 2

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Regulation 880.5970

4510(k)s in 12 months (303 all time)
9recalls in 12 months (332 all time)
305recalls that name a 510(k)
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Top companies in LJS

Decided510(k)Device and applicantCode
Oct 9, 2026K260080Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler
Medical Components, Inc.
LJS
Apr 17, 2026K260929Neonav ECG Tip Location System
Navi Medical Technologies, AU
LJS
Dec 16, 2025K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve T
Spectrum Vascular
LJS
Nov 17, 2025K252792PM2™ System with ECGuide™ Connector
Piccolo Medical, Inc.
LJS
Aug 1, 2025K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked c
Access Vascular, Inc.
LJS
Jul 1, 2025K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM
Access Vascular, Inc.
LJS
May 29, 2025K243484PM2+ System and SmartPICC Stylet
Piccolo Medical, Inc.
LJS
Feb 26, 2025K241587pilot TLS
Vygon Corporation
LJS
Jan 19, 2025K241910Neonav ECG Tip Location System
Navi Medical Technologies, AU
LJS
Jan 17, 2025K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked
Access Vascular, Inc.
LJS
Sep 8, 2024K240486PM2 System and ECGuide Connector
Piccolo Medical, Inc.
LJS
Dec 1, 2023K233149CATHTONG III Tapered PICC Catheter
L&Z Us, Inc.
LJS
Nov 30, 2023K230669L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters
Argon Medical Devices
LJS
Sep 22, 2023K232594CATHTONG™ II PICC Catheter
L&Z Us, Inc.
LJS
Sep 22, 2023K232571CATHTONG™ II PICC Catheter
L&Z Us, Inc.
LJS
Aug 24, 2022K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
Bard Access Systems, Inc.
LJS
Aug 22, 2022K220363VPS Rhythm DLX Device with TipTracker Technology
Arrow International, LLC (A subsidiary of Teleflex, Inc.)
LJS
May 4, 2022K213550HydroPICC 5F Dual Lumen Catheter
Access Vascular, Inc.
LJS
Jul 30, 2021K210264BD PowerPiCC Catheter
Bard Access Systems, Inc.
LJS
Mar 12, 2021K201452Groshong NXT PICC Catheter
C.R. Bard, Inc.
LJS
Jan 22, 2021K200037Piccolo Medical SmartPICC System
Piccolo Medical, Inc.
LJS
Apr 30, 2020K192246Biowy PICC Catheter S Kit
Biowy Corporation
LJS
Feb 20, 2020K193015HydroPICC (PICC-142)
Access Vascular, Inc.
LJS
Nov 21, 2018K180546Jet Power Injectable PICC
Jet Medical, Inc.
LJS
Sep 25, 2018K1819045 FR Dual Lumen Piper PICC
Piper Access, LLC
LJS
Jun 18, 2018K180560Sherlock 3CG+ T ip Confirmation System
C.R. Bard, Inc.
LJS
May 21, 2018K173956Biowy PlCC Catheter
Biowy Corporation
LJS
Apr 26, 2018K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Cathe
C.R. Bard, Inc (Bard Has Joined Bd)
LJS
Apr 20, 2018K172511Hickman TriFusion Catheter
C.R. Bard, Inc.
LJS
Apr 12, 2018K180567C3 Wave System
Medical Components, Inc. (dba MedComp)
LJS
Feb 26, 2018K172899Vygon PICCs
Vygon USA
LJS
Feb 22, 2018K171994Silicone Peripherally Inserted Central Venous Catheter Set/Tray
Cook Incorporated
LJS
Feb 20, 2018K172885HydroPICC
Access Vascular, Inc.
LJS
Dec 6, 2017K170934C3 Wave System
Medical Components, Inc (Dba Medcomp_
LJS
Oct 26, 2017K171931Celerity ECG Cable Accessory Pack
Medcomp (Medical Components, Inc.)
LJS
Sep 29, 2017K172397Sherlock 3CG Tip Positioning System Stylet
C.R. Bard, Inc.
LJS
Aug 3, 2017K172039CATHTONG II PICC Catheter
L&Z Us, Inc.
LJS
May 25, 2017K170486CATHTONG II PICC Catheter
L&Z Us, Inc.
LJS
Apr 24, 2017K162441PowerPICC Provena Catheters with SOLO Valve Technology
C.R. Bard, Inc.
LJS
Feb 3, 2017K163452PICC Maximal Barrier Nursing Kit
Navilyst Medical, Inc.
LJS
Dec 22, 2016K160925VPS Rhythm Device with TipTracker Technology
Arrow International, Inc. (A Subsidiary of Teleflex, Inc.)
LJS
Oct 25, 2016K162443PowerPICC Provena Catheters
C.R. Bard, Inc.
LJS
Oct 7, 2016K161496Turbo-Flo PICC Sets
Cook Incorporated
LJS
Sep 6, 2016K161765CG+ Arrow JACC
Arrow International, Inc. (Subsidiary of Teleflex
LJS
Sep 1, 2016K153469Cathtong I PICC Catheter
L&Z Us, Inc.
LJS
Jun 14, 2016K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
C.R. Bard, Inc.
LJS
Feb 5, 2016K152819Amecath Peripheral inserted Central Venous Catheter Sets
Ameco Medical Industries, EG
LJS
Feb 4, 2016K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
LJS
Jan 28, 2016K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
LJS
Oct 21, 2015K152261PICC Tip Positioning Aid
Nostix, LLC
LJS

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