Product code LJS
- Device name
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5970
- Review panel
- HO
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260929 | Neonav ECG Tip Location System | Navi Medical Technologies | 2026-04-17 |
| 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 ... | Spectrum Vascular | 2025-12-16 |
| K252792 | PM2™ System with ECGuide™ Connector | Piccolo Medical, Inc. | 2025-11-17 |
| 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 (70... | Access Vascular, Inc. | 2025-08-01 |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) | Access Vascular, Inc. | 2025-07-01 |
| K243484 | PM2+ System and SmartPICC Stylet | Piccolo Medical, Inc. | 2025-05-29 |
| K241587 | pilot TLS | Vygon Corporation | 2025-02-26 |
| K241910 | Neonav ECG Tip Location System | Navi Medical Technologies | 2025-01-19 |
| 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 (700... | Access Vascular, Inc. | 2025-01-17 |
| K240486 | PM2 System and ECGuide Connector | Piccolo Medical, Inc. | 2024-09-08 |
| K233149 | CATHTONG III Tapered PICC Catheter | L&Z Us, Inc. | 2023-12-01 |
| K230669 | L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters | Argon Medical Devices | 2023-11-30 |
| K232594 | CATHTONG™ II PICC Catheter | L&Z Us, Inc. | 2023-09-22 |
| K232571 | CATHTONG™ II PICC Catheter | L&Z Us, Inc. | 2023-09-22 |
| K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly | Bard Access Systems, Inc. | 2022-08-24 |
| K220363 | VPS Rhythm DLX Device with TipTracker Technology | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022-08-22 |
| K213550 | HydroPICC 5F Dual Lumen Catheter | Access Vascular, Inc. | 2022-05-04 |
| K210264 | BD PowerPiCC Catheter | Bard Access Systems, Inc. | 2021-07-30 |
| K201452 | Groshong NXT PICC Catheter | C.R. Bard, Inc. | 2021-03-12 |
| K200037 | Piccolo Medical SmartPICC System | Piccolo Medical, Inc. | 2021-01-22 |
| K192246 | Biowy PICC Catheter S Kit | Biowy Corporation | 2020-04-30 |
| K193015 | HydroPICC (PICC-142) | Access Vascular, Inc. | 2020-02-20 |
| K180546 | Jet Power Injectable PICC | Jet Medical, Inc. | 2018-11-21 |
| K181904 | 5 FR Dual Lumen Piper PICC | Piper Access, LLC | 2018-09-25 |
| K180560 | Sherlock 3CG+ T ip Confirmation System | C.R. Bard, Inc. | 2018-06-18 |
| K173956 | Biowy PlCC Catheter | Biowy Corporation | 2018-05-21 |
| K180548 | 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology | C.R. Bard, Inc (Bard Has Joined Bd) | 2018-04-26 |
| K172511 | Hickman TriFusion Catheter | C.R. Bard, Inc. | 2018-04-20 |
| K180567 | C3 Wave System | Medical Components, Inc. (dba MedComp) | 2018-04-12 |
| K172899 | Vygon PICCs | Vygon USA | 2018-02-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00801741240041 | PowerPICC Provena SOLO | Bard Access Systems, Inc. | 2026-05-27 |
| 00801741240058 | PowerPICC Provena SOLO | Bard Access Systems, Inc. | 2026-05-27 |
| 00801741240065 | PowerPICC Provena SOLO Catheter with Sherlock 3CG | Bard Access Systems, Inc. | 2026-05-27 |
| 00801741240072 | PowerPICC Provena SOLO Catheter with Sherlock 3CG | Bard Access Systems, Inc. | 2026-05-27 |
| 00801741240034 | PowerPICC SOLO | Bard Access Systems, Inc. | 2026-05-27 |
| 08498840011072 | VYGON | Vygon Corporation | 2019-02-26 |
| 08498840011065 | VYGON | Vygon Corporation | 2019-02-26 |
| 08498840011058 | VYGON | Vygon Corporation | 2019-02-26 |
| 08498840011164 | VYGON | Vygon Corporation | 2017-11-21 |
| 08498840011157 | VYGON | Vygon Corporation | 2017-11-21 |
| 08498840011140 | VYGON | Vygon Corporation | 2017-11-21 |
| 08498840000168 | VYGON | Vygon Corporation | 2016-08-18 |
| 08498840008508 | Premicath | Vygon Corporation | 2015-10-08 |
| 08498840000137 | Nutriline Twinflo | Vygon Corporation | 2015-10-08 |
| 08498840000182 | LIFECATH S | Vygon Corporation | 2015-10-08 |
| 08498840000199 | LIFECATH S | Vygon Corporation | 2015-10-08 |
| 08498840008478 | Premicath | Vygon Corporation | 2015-10-08 |
| 08498840008485 | Premicath | Vygon Corporation | 2015-10-08 |
| 08498840009536 | Premicath | Vygon Corporation | 2015-10-08 |
| 08498840009451 | Nutriline Twinflo | Vygon Corporation | 2015-10-08 |
| 08498840009437 | Nutriline | Vygon Corporation | 2015-10-08 |
| 08498840009420 | Nutriline | Vygon Corporation | 2015-10-08 |
| 08498840009406 | Nutriline | Vygon Corporation | 2015-10-08 |
| 08498840008546 | LIFECATH S | Vygon Corporation | 2015-10-08 |
| 08498840008539 | LIFECATH S | Vygon Corporation | 2015-10-08 |
| 08498840008522 | Premicath | Vygon Corporation | 2015-10-08 |
| 08498840008515 | Premicath | Vygon Corporation | 2015-10-08 |
| 08498840008492 | Premicath | Vygon Corporation | 2015-10-08 |
| 08498840009444 | Nutriline Twinflo | Vygon Corporation | 2015-10-07 |
| 08498840009468 | Nutriline | Vygon Corporation | 2015-10-07 |