510(k) K971966
K971966 is an FDA 510(k) premarket notification submitted by Med-Edge, Inc. for the device "CORONARY VEIN GRAFT TAG MARKER". The FDA issued a decision of Substantially Equivalent on January 26, 1998. The device falls under product code KPK (Marker, Ostia, Aorto-Saphenous Vein), a Class II device regulated under 21 CFR 878.4650. Med-Edge, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1998
- Date Received
- May 28, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Ostia, Aorto-Saphenous Vein
- Device Class
- Class II
- Regulation Number
- 878.4650
- Review Panel
- CV
- Submission Type