K896415 is an FDA 510(k) clearance for the USCI PRESTO DISPOSABLE INFLATION DEVICE. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on January 19, 1990, 72 days after receiving the submission on November 8, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K896415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1989 |
| Decision Date | January 19, 1990 |
| Days to Decision | 72 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 |