K831854 is an FDA 510(k) clearance for the USCI ANGIOGRAPHIC BALLOON CATHETER. This device is classified as a Catheter, Flow Directed (Class II - Special Controls, product code DYG).
Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on October 20, 1983, 133 days after receiving the submission on June 9, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1240.
| 510(k) Number | K831854 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1983 |
| Decision Date | October 20, 1983 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DYG — Catheter, Flow Directed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1240 |