510(k) K073523

INTERCEPTOR PLUS CORONARY FILTER SYSTEMS by Medtronic, Inc. — Product Code NFA

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