K910873 is an FDA 510(k) clearance for the BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 29, 1991, 89 days after receiving the submission on March 1, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K910873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1991 |
| Decision Date | May 29, 1991 |
| Days to Decision | 89 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 |