EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
FDA 510(k) clearance K052964 · decided 2006-01-06
Clearance details
- K-number
- K052964
- Device name
- EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2005-10-21
- Decision date
- 2006-01-06
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- DSY
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intende recall (Z-1606-2010) | Maquet Cardiovascular, LLC | 2010-05-14 |
| EXXCEL Soft Thin Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intended us recall (Z-1607-2010) | Maquet Cardiovascular, LLC | 2010-05-14 |
| EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovas recall (Z-0866-2010) | Maquet Cardiovascular, LLC | 2010-02-26 |