K911140 is an FDA 510(k) clearance for the BARD(R) ENDOCARDIAL BALLOON ARRAY. This device is classified as a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II - Special Controls, product code DRF).
Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on May 7, 1991, 54 days after receiving the submission on March 14, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K911140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1991 |
| Decision Date | May 07, 1991 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |