K782018 is an FDA 510(k) clearance for the LEADS, IMPLANTABLE CARDIAC PACEMAKERS. 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 June 4, 1979, 181 days after receiving the submission on December 5, 1978.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K782018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1978 |
| Decision Date | June 04, 1979 |
| Days to Decision | 181 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 |