K173923 is an FDA 510(k) clearance for the Temporary Cardiac Pacing Wire. This device is classified as a Electrode, Pacemaker, Temporary (Class II - Special Controls, product code LDF).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on August 2, 2018, 219 days after receiving the submission on December 26, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K173923 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2017 |
| Decision Date | August 02, 2018 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LDF — Electrode, Pacemaker, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3680 |