K823920 is an FDA 510(k) clearance for the COEURLOCK STERILE DISPOS. ANGIOGRAPHIC. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Coeur Laboratories, Inc.. The FDA issued a Cleared decision on February 18, 1983, 52 days after receiving the submission on December 28, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K823920 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 1982 |
| Decision Date | February 18, 1983 |
| Days to Decision | 52 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 |