510(k) K051179
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2005
- Date Received
- May 9, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type