510(k) K211806 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter
| Applicant | Venclose, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Aug 3, 2021 |
| Received | Jun 11, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211806
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2025 | Bard Peripheral Vascular Inc Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sop Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.