K865098 is an FDA 510(k) clearance for the SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438. This device is classified as a Permanent Pacemaker Electrode (Class III - Premarket Approval, product code DTB).
Submitted by Telectronics, Inc. (Suffield, US). The FDA issued a Cleared decision on August 18, 1987, 231 days after receiving the submission on December 30, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K865098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1986 |
| Decision Date | August 18, 1987 |
| Days to Decision | 231 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 |