VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM
FDA 510(k) clearance K101274 · decided 2010-06-11
Clearance details
- K-number
- K101274
- Device name
- VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM
- Applicant
- Maquet Cardiovascular, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-05-06
- Decision date
- 2010-06-11
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Jose, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM (P840029/S007) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD ETS(TM) FLANGED GRAFT (P840029/S004) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 12 X 6MM (P840029/S006) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD(R) MICROVEL (R) DOUBLE VELOUR GRAFT (P840029/S014) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD (R) MICROVEL (R) DOUBLE VELOUR (P840029/S011) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S010) | Maquet Cardiovascular, LLC | 1993-05-11 |
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S009) | Maquet Cardiovascular, LLC | 1993-05-11 |
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S005) | Maquet Cardiovascular, LLC | 1993-05-11 |