K830094 is an FDA 510(k) clearance for the USCI TEMP. ATRIO-VENTRICULAR ELECTRODE. This device is classified as a Electrode, Pacemaker, Temporary (Class II - Special Controls, product code LDF).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 18, 1983, 38 days after receiving the submission on January 11, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K830094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 1983 |
| Decision Date | February 18, 1983 |
| Days to Decision | 38 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 |