K913288 is an FDA 510(k) clearance for the MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS. This device is classified as a Permanent Pacemaker Electrode (Class III - Premarket Approval, product code DTB).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on October 17, 1991, 85 days after receiving the submission on July 24, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K913288 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 1991 |
| Decision Date | October 17, 1991 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTB — Permanent Pacemaker Electrode |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3680 |