Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter
FDA 510(k) clearance K211806 · decided 2021-08-03
Clearance details
- K-number
- K211806
- Device name
- Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter
- Applicant
- Venclose, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-11
- Decision date
- 2021-08-03
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal recall (Z-2638-2025) | Bard Peripheral Vascular Inc | 2025-09-26 |