K955722 is an FDA 510(k) clearance for the FLEXON TEMPORARY CARDIAC PACER LEAD. This device is classified as a Electrode, Pacemaker, Temporary (Class II - Special Controls, product code LDF).
Submitted by Davis & Geck, Inc. (Danbury, US). The FDA issued a Cleared decision on March 15, 1996, 88 days after receiving the submission on December 18, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K955722 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 1995 |
| Decision Date | March 15, 1996 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | LDF — Electrode, Pacemaker, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3680 |