510(k) K011589
CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M by
Bypass , Ltd.
— Product Code NCA
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 26, 2001
- Date Received
- May 23, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type