K896632 is an FDA 510(k) clearance for the MEDTRONIC MODEL 5401B TEST CABLE. This device is classified as a Analyzer, Pacemaker Generator Function (Class II - Special Controls, product code DTC).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 13, 1989, 21 days after receiving the submission on November 22, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3630.
| 510(k) Number | K896632 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1989 |
| Decision Date | December 13, 1989 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTC — Analyzer, Pacemaker Generator Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3630 |