3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology
FDA 510(k) clearance K180548 · decided 2018-04-26
Clearance details
- K-number
- K180548
- Device name
- 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology
- Applicant
- C.R. Bard, Inc (Bard Has Joined Bd)
- Decision
- Substantially Equivalent
- Date received
- 2018-03-01
- Decision date
- 2018-04-26
- Days to decision
- 56 days
- Clearance type
- Special
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake Ciy,, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK00 recall (Z-2664-2026) | Bard Access Systems, Inc. | 2026-07-02 |