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)
FDA 510(k) clearance K243941 · decided 2025-01-17
Clearance details
- K-number
- K243941
- Device name
- 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)
- Applicant
- Access Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-12-20
- Decision date
- 2025-01-17
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ballerica, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Neonav ECG Tip Location System (K260929) | Navi Medical Technologies | 2026-04-17 |
| 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 (K252373) | Spectrum Vascular | 2025-12-16 |
| PM2™ System with ECGuide™ Connector (K252792) | Piccolo Medical, Inc. | 2025-11-17 |
| 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 (K243458) | Access Vascular, Inc. | 2025-08-01 |
| Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) (K251212) | Access Vascular, Inc. | 2025-07-01 |
| PM2+ System and SmartPICC Stylet (K243484) | Piccolo Medical, Inc. | 2025-05-29 |
| pilot TLS (K241587) | Vygon Corporation | 2025-02-26 |
| Neonav ECG Tip Location System (K241910) | Navi Medical Technologies | 2025-01-19 |
| PM2 System and ECGuide Connector (K240486) | Piccolo Medical, Inc. | 2024-09-08 |
| CATHTONG III Tapered PICC Catheter (K233149) | L&Z Us, Inc. | 2023-12-01 |
| L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters (K230669) | Argon Medical Devices | 2023-11-30 |
| CATHTONG™ II PICC Catheter (K232571) | L&Z Us, Inc. | 2023-09-22 |
Recalls involving this device
No recalls on record reference this clearance.