K895789 is an FDA 510(k) clearance for the UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490. 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 December 7, 1989, 70 days after receiving the submission on September 28, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K895789 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 1989 |
| Decision Date | December 07, 1989 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | LDF — Electrode, Pacemaker, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3680 |