K882330 is an FDA 510(k) clearance for the BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER. This device is classified as a Electrode, Pacemaker, Temporary (Class II - Special Controls, product code LDF).
Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on September 6, 1988, 92 days after receiving the submission on June 6, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K882330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 1988 |
| Decision Date | September 06, 1988 |
| Days to Decision | 92 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 |