EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
FDA 510(k) clearance K113101 · decided 2012-01-17
Clearance details
- K-number
- K113101
- Device name
- EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-10-19
- Decision date
- 2012-01-17
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- DSY
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wayne, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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