K963898 is an FDA 510(k) clearance for the MODEL 6495 BIPOLAR TEMPORARY PACING LEAD. This device is classified as a Electrode, Pacemaker, Temporary (Class II - Special Controls, product code LDF).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on July 22, 1997, 298 days after receiving the submission on September 27, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K963898 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1996 |
| Decision Date | July 22, 1997 |
| Days to Decision | 298 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LDF — Electrode, Pacemaker, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3680 |