K914460 is an FDA 510(k) clearance for the MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES. This device is classified as a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II - Special Controls, product code DRF).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on November 22, 1991, 46 days after receiving the submission on October 7, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K914460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1991 |
| Decision Date | November 22, 1991 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |