K962036 is an FDA 510(k) clearance for the MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD. 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 August 22, 1996, 90 days after receiving the submission on May 24, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K962036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | May 24, 1996 |
| Decision Date | August 22, 1996 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTB — Permanent Pacemaker Electrode |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3680 |