K791732 is an FDA 510(k) clearance for the IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC. This device is classified as a Permanent Pacemaker Electrode (Class III - Premarket Approval, product code DTB).
Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on September 19, 1979, 14 days after receiving the submission on September 5, 1979.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K791732 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1979 |
| Decision Date | September 19, 1979 |
| Days to Decision | 14 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 |