K874664 is an FDA 510(k) clearance for the IMPLANTABLE ELECTRODE LEAD, MODEL 030-446. 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 May 31, 1988, 200 days after receiving the submission on November 13, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K874664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1987 |
| Decision Date | May 31, 1988 |
| Days to Decision | 200 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 |