LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days Class II
FDA Device Classification
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 |
|---|
| 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 |
| K232571 | l and z us | CATHTONG II PICC Catheter | September 22, 2023 |
| K232594 | 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 |
| K192246 | biowy corporation | Biowy PICC Catheter S Kit | April 30, 2020 |