K915188 is an FDA 510(k) clearance for the MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD. This device is classified as a Permanent Pacemaker Electrode (Class III - Premarket Approval, product code DTB).
Submitted by Cook Pacemaker Corp. (Leechburg, US). The FDA issued a Cleared decision on September 11, 1992, 298 days after receiving the submission on November 18, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K915188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | November 18, 1991 |
| Decision Date | September 11, 1992 |
| Days to Decision | 298 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTB — Permanent Pacemaker Electrode |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3680 |