K921124 is an FDA 510(k) clearance for the MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS. 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 May 22, 1992, 102 days after receiving the submission on February 10, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K921124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | February 10, 1992 |
| Decision Date | May 22, 1992 |
| Days to Decision | 102 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 |