LJS · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
General Hospital · 21 CFR 880.5970 · Class 2
Overview
| Product Code | LJS |
|---|---|
| Device Name | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Regulation | 21 CFR 880.5970 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| Implant | Yes |
Identification
A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.
Classification Rationale
Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
Special Controls
*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
Recent Cleared Devices (20 of 302)
Showing 20 most recent of 302 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260929 | Neonav ECG Tip Location System | Navi Medical Technologies | Apr 17, 2026 | SESE |
| K252373 | 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 | Spectrum Vascular | Dec 16, 2025 | SESE |
| K252792 | PM2 System with ECGuide Connector | Piccolo Medical, Inc. | Nov 17, 2025 | SESE |
| K243458 | 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 | Access Vascular, Inc. | Aug 1, 2025 | SESE |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) | Access Vascular, Inc. | Jul 1, 2025 | SESE |
| K243484 | PM2+ System and SmartPICC Stylet | Piccolo Medical, Inc. | May 29, 2025 | SESE |
| K241587 | pilot TLS | Vygon Corporation | Feb 26, 2025 | SESE |
| K241910 | Neonav ECG Tip Location System | Navi Medical Technologies | Jan 19, 2025 | SESE |
| K243941 | 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) | Access Vascular, Inc. | Jan 17, 2025 | SESE |
| K240486 | PM2 System and ECGuide Connector | Piccolo Medical, Inc. | Sep 8, 2024 | SESE |
| K233149 | CATHTONG III Tapered PICC Catheter | L&Z Us, Inc. | Dec 1, 2023 | SESE |
| K230669 | L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters | Argon Medical Devices | Nov 30, 2023 | SESE |
| K232594 | CATHTONG II PICC Catheter | L&Z Us, Inc. | Sep 22, 2023 | SESE |
| K232571 | CATHTONG II PICC Catheter | L&Z Us, Inc. | Sep 22, 2023 | SESE |
| K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly | Bard Access Systems, Inc. | Aug 24, 2022 | SESE |
| K220363 | VPS Rhythm DLX Device with TipTracker Technology | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | Aug 22, 2022 | SESE |
| K213550 | HydroPICC 5F Dual Lumen Catheter | Access Vascular, Inc. | May 4, 2022 | SESE |
| K210264 | BD PowerPiCC Catheter | Bard Access Systems, Inc. | Jul 30, 2021 | SESE |
| K201452 | Groshong NXT PICC Catheter | C.R. Bard, Inc. | Mar 12, 2021 | SESE |
| K200037 | Piccolo Medical SmartPICC System | Piccolo Medical, Inc. | Jan 22, 2021 | SESE |
Top Applicants
- C.R. Bard, Inc. — 34 clearances
- Navilyst Medical, Inc. — 16 clearances
- Medcomp — 11 clearances
- AngioDynamics, Inc. — 10 clearances
- Vygon Corp. — 10 clearances
