LJS
- Product code
- LJS
- Device name
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5970
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 302
510(k) clearances, last 3 years (14)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K260929 | 2026-04-17 | Navi Medical Technologies | Neonav ECG Tip Location System summary |
| K252373 | 2025-12-16 | Spectrum Vascular | BioFlo Hybrid PICC with ENDEXO Technology and PASV V summary |
| K252792 | 2025-11-17 | Piccolo Medical, Inc. | PM2 System with ECGuide Connector summary |
| K243458 | 2025-08-01 | Access Vascular, Inc. | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm g summary |
| K251212 | 2025-07-01 | Access Vascular, Inc. | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PIC summary |
| K243484 | 2025-05-29 | Piccolo Medical, Inc. | PM2+ System and SmartPICC Stylet summary |
| K241587 | 2025-02-26 | Vygon Corporation | pilot TLS summary |
| K241910 | 2025-01-19 | Navi Medical Technologies | Neonav ECG Tip Location System summary |
| K243941 | 2025-01-17 | Access Vascular, Inc. | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm g summary |
| K240486 | 2024-09-08 | Piccolo Medical, Inc. | PM2 System and ECGuide Connector summary |
| K233149 | 2023-12-01 | L&Z Us, Inc. | CATHTONG III Tapered PICC Catheter |
| K230669 | 2023-11-30 | Argon Medical Devices | L-Cath Single and Dual Lumen Catheters, L-Cath Mid summary |
| K232594 | 2023-09-22 | L&Z Us, Inc. | CATHTONG II PICC Catheter |
| K232571 | 2023-09-22 | L&Z Us, Inc. | CATHTONG II PICC Catheter |
Official FDA classification page: LJS
Classification and pathway per current FDA publications. Data from openFDA (CC0).