K083523 is an FDA 510(k) clearance for the MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 4, 2009, 70 days after receiving the submission on November 26, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K083523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2008 |
| Decision Date | February 04, 2009 |
| Days to Decision | 70 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXT — Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |