510(k) K153194 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
VASOVIEW HemoPro Endoscopic Vessel Harvesting System
| Applicant | Maquet Cardiovascular, LLC, Wayne NJ, US |
| Decision | Substantially Equivalent, Apr 19, 2016 |
| Received | Nov 4, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153194
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 25, 2024 | Maquet Cardiovascular, LLC VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500 Open, Classified |
GEI | None listed |
| Jul 11, 2024 | Maquet Cardiovascular, LLC The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, Open, Classified |
GEI | None listed |
| Jun 24, 2024 | Maquet Cardiovascular, LLC The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, Open, Classified |
GEI | None listed |
| Jan 12, 2024 | Maquet Cardiovascular, LLC Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. Open, Classified |
GEI | None listed |
| Apr 4, 2023 | Maquet Cardiovascular, LLC VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500 Open, Classified |
GEI | None listed |
| Apr 4, 2023 | Maquet Cardiovascular, LLC VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W Open, Classified |
GEI | None listed |
| Jan 27, 2017 | Maquet Cardiovascular, LLC VASOVIEW HEMOPRO VH-3500
ENDOSCOPIC VESSEL HARVESTING SYSTEM
Product Usage:
The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use wi Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.