K823446 is an FDA 510(k) clearance for the PRODUCTS IMPLANTABLE PACING LEAD,TINED. 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 December 3, 1982, 17 days after receiving the submission on November 16, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K823446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 1982 |
| Decision Date | December 03, 1982 |
| Days to Decision | 17 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 |