LJS · Class II · 21 CFR 880.5970

FDA Product Code LJS: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

Under FDA product code LJS, long-term implanted intravascular therapeutic catheters are cleared for extended vascular access over weeks to months.

These tunneled or implanted central venous catheters provide durable, reliable access to the central venous circulation for long-term chemotherapy, parenteral nutrition, hemodialysis, and repeated blood sampling without repeated peripheral venipuncture.

LJS devices are Class II medical devices, regulated under 21 CFR 880.5970 and reviewed by the FDA General Hospital panel.

Leading manufacturers include C.R. Bard, Inc., Access Vascular, Inc. and Piccolo Medical, Inc..

302
Total
302
Cleared
131d
Avg days
1983
Since
Growing category - 10 submissions in the last 2 years vs 6 in the prior period
Consistent review times: 148d avg (recent)

FDA 510(k) Cleared Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days Devices (Product Code LJS)

302 devices
1–24 of 302
Cleared Apr 17, 2026
Neonav ECG Tip Location System
K260929
Navi Medical Technologies
Cardiovascular · 28d
Cleared Dec 16, 2025
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology
K252373
Spectrum Vascular
General Hospital · 139d
Cleared Nov 17, 2025
PM2™ System with ECGuide™ Connector
K252792
Piccolo Medical, Inc.
Cardiovascular · 76d
Cleared Aug 01, 2025
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)
K243458
Access Vascular, Inc.
General Hospital · 266d
Cleared Jul 01, 2025
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM)
K251212
Access Vascular, Inc.
General Hospital · 74d
Cleared May 29, 2025
PM2+ System and SmartPICC Stylet
K243484
Piccolo Medical, Inc.
Cardiovascular · 202d
Cleared Feb 26, 2025
pilot TLS
K241587
Vygon Corporation
Cardiovascular · 268d
Cleared Jan 19, 2025
Neonav ECG Tip Location System
K241910
Navi Medical Technologies
Cardiovascular · 202d
Cleared Jan 17, 2025
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)
K243941
Access Vascular, Inc.
General Hospital · 28d
Cleared Sep 08, 2024
PM2 System and ECGuide Connector
K240486
Piccolo Medical, Inc.
Cardiovascular · 201d
Cleared Dec 01, 2023
CATHTONG III Tapered PICC Catheter
K233149
L&Z Us, Inc.
General Hospital · 65d
Cleared Nov 30, 2023
L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters
K230669
Argon Medical Devices
General Hospital · 265d
Cleared Sep 22, 2023
CATHTONG™ II PICC Catheter
K232571
L&Z Us, Inc.
General Hospital · 29d
Cleared Sep 22, 2023
CATHTONG™ II PICC Catheter
K232594
L&Z Us, Inc.
General Hospital · 28d
Cleared Aug 24, 2022
Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
K222232
Bard Access Systems, Inc.
General Hospital · 30d
Cleared Aug 22, 2022
VPS Rhythm DLX Device with TipTracker Technology
K220363
Arrow International, LLC (A subsidiary of Teleflex, Inc.)
General Hospital · 195d
Cleared May 04, 2022
HydroPICC 5F Dual Lumen Catheter
K213550
Access Vascular, Inc.
General Hospital · 177d
Cleared Jul 30, 2021
BD PowerPiCC Catheter
K210264
Bard Access Systems, Inc.
General Hospital · 179d
Cleared Mar 12, 2021
Groshong NXT PICC Catheter
K201452
C.R. Bard, Inc.
General Hospital · 284d
Cleared Jan 22, 2021
Piccolo Medical SmartPICC System
K200037
Piccolo Medical, Inc.
Cardiovascular · 380d
Cleared Apr 30, 2020
Biowy PICC Catheter S Kit
K192246
Biowy Corporation
General Hospital · 255d
Cleared Feb 20, 2020
HydroPICC (PICC-142)
K193015
Access Vascular, Inc.
General Hospital · 114d
Cleared Nov 21, 2018
Jet Power Injectable PICC
K180546
Jet Medical, Inc.
General Hospital · 265d
Cleared Sep 25, 2018
5 FR Dual Lumen Piper PICC
K181904
Piper Access, LLC
General Hospital · 71d

About Product Code LJS - Regulatory Context

510(k) Submission Activity

302 total 510(k) submissions under product code LJS since 1983, with 302 receiving FDA clearance (average review time: 131 days).

Submission volume has increased in recent years - 10 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LJS Product Code

FDA review times for LJS submissions have been consistent, averaging 148 days recently vs 130 days historically.

LJS devices are reviewed by the General Hospital panel. Browse all General Hospital devices →