510(k) K073523
K073523 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "INTERCEPTOR PLUS CORONARY FILTER SYSTEMS". The FDA issued a decision of Substantially Equivalent on August 1, 2008. The device falls under product code NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection), a Class II device regulated under 21 CFR 870.1250. Medtronic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2008
- Date Received
- December 14, 2007
- Clearance Type
- Traditional
- 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