K791782 is an FDA 510(k) clearance for the USCI BALLOON DILATATION INFLATION DEV.. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 11, 1979, 90 days after receiving the submission on September 12, 1979.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K791782 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 1979 |
| Decision Date | December 11, 1979 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXT — Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |