K011811 is an FDA 510(k) clearance for the MONARCH INFLATION 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 August 22, 2001, 72 days after receiving the submission on June 11, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K011811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2001 |
| Decision Date | August 22, 2001 |
| Days to Decision | 72 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 |