K831695 is an FDA 510(k) clearance for the TEMP. CARDIAC PACING WIRE TME 60/61/65. This device is classified as a Electrode, Pacemaker, Temporary (Class II - Special Controls, product code LDF).
Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on October 20, 1983, 148 days after receiving the submission on May 25, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K831695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 1983 |
| Decision Date | October 20, 1983 |
| Days to Decision | 148 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 |