510(k) K140603 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM
| Applicant | Saphena Medical, Inc., Mission Viejo CA, US |
| Decision | Substantially Equivalent, Jul 31, 2014 |
| Received | Mar 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140603
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2024 | Zimmer, Inc. Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopi Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.