510(k) K251238 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)
| Applicant | Maquet Cardiovascular, LLC, Wayne NJ, US |
| Decision | Substantially Equivalent, May 30, 2025 |
| Received | Apr 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251238
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2025 | Maquet Cardiovascular, LLC Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000.
The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting ki Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.