LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days Class II
FDA product code LJS covers "Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days", a Class II medical device regulated under 21 CFR 880.5970. Submissions are reviewed by the General Hospital panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LJS
- Device Class
- Class II
- Regulation Number
- 880.5970
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260929 | navi medical technologies | Neonav ECG Tip Location System | April 17, 2026 |
| K252373 | spectrum vascular | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC | December 16, 2025 |
| K252792 | piccolo medical | PM2 System with ECGuide Connector | November 17, 2025 |
| K243458 | access vascular | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (700013 | August 1, 2025 |
| K251212 | access vascular | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr Hyd | July 1, 2025 |
| K243484 | piccolo medical | PM2+ System and SmartPICC Stylet | May 29, 2025 |
| K241587 | vygon corporation | pilot TLS | February 26, 2025 |
| K241910 | navi medical technologies | Neonav ECG Tip Location System | January 19, 2025 |
| K243941 | access vascular | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001 | January 17, 2025 |
| K240486 | piccolo medical | PM2 System and ECGuide Connector | September 8, 2024 |
| K233149 | l and z us | CATHTONG III Tapered PICC Catheter | December 1, 2023 |
| K230669 | argon medical devices | L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters | November 30, 2023 |
| K232594 | l and z us | CATHTONG II PICC Catheter | September 22, 2023 |
| K232571 | l and z us | CATHTONG II PICC Catheter | September 22, 2023 |
| K222232 | bard access systems | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly | August 24, 2022 |
| K220363 | arrow international, llc (a subsidiary of teleflex, inc.) | VPS Rhythm DLX Device with TipTracker Technology | August 22, 2022 |
| K213550 | access vascular | HydroPICC 5F Dual Lumen Catheter | May 4, 2022 |
| K210264 | bard access systems | BD PowerPiCC Catheter | July 30, 2021 |
| K201452 | c.r. bard | Groshong NXT PICC Catheter | March 12, 2021 |
| K200037 | piccolo medical | Piccolo Medical SmartPICC System | January 22, 2021 |