K023878 is an FDA 510(k) clearance for the GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM. 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 Vascular (Danvers, US). The FDA issued a Cleared decision on January 24, 2003, 64 days after receiving the submission on November 21, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K023878 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2002 |
| Decision Date | January 24, 2003 |
| Days to Decision | 64 days |
| Submission Type | Special |
| 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 |