K073523 is an FDA 510(k) clearance for the INTERCEPTOR PLUS CORONARY FILTER SYSTEMS. This device is classified as a Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection (Class II - Special Controls, product code NFA).
Submitted by Medtronic, Inc. (Danvers, US). The FDA issued a Cleared decision on August 1, 2008, 231 days after receiving the submission on December 14, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K073523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2007 |
| Decision Date | August 01, 2008 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NFA — Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |