K863547 is an FDA 510(k) clearance for the MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE. This device is classified as a Pacemaker, Cardiac, External Transcutaneous (non-invasive) (Class II - Special Controls, product code DRO).
Submitted by Medtronic Vascular (Lawrence, US). The FDA issued a Cleared decision on October 31, 1986, 49 days after receiving the submission on September 12, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5550.
| 510(k) Number | K863547 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 1986 |
| Decision Date | October 31, 1986 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRO — Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5550 |