GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000
FDA 510(k) clearance K052274 · decided 2005-09-21
Clearance details
- K-number
- K052274
- Device name
- GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000
- Applicant
- Guidant Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-08-22
- Decision date
- 2005-09-21
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500 recall (Z-0092-2025) | Maquet Cardiovascular, LLC | 2024-10-25 |
| Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . recall (Z-0723-2024) | Maquet Cardiovascular, LLC | 2024-01-12 |
| Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour recall (Z-0466-2014) | Maquet Cardiovascular, LLC | 2013-12-06 |
| VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascula recall (Z-3272-2011) | Maquet Cardiovascular, LLC | 2011-09-20 |