GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004
FDA 510(k) clearance K041981 · decided 2004-08-20
Clearance details
- K-number
- K041981
- Device name
- GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004
- Applicant
- Guidant Corporation
- Decision
- Substantially Equivalent
- Date received
- 2004-07-23
- Decision date
- 2004-08-20
- Days to decision
- 28 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 6 Endoscopic Vessel Harvesting System Manufactured by Maquet Cardiovascular, LLC; recall (Z-3270-2011) | Maquet Cardiovascular, LLC | 2011-09-20 |
| VASOVIEW 7xB Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascular, L recall (Z-3271-2011) | Maquet Cardiovascular, LLC | 2011-09-20 |