K943597 is an FDA 510(k) clearance for the MONARCH AP(TM). This device is classified as a Syringe, Balloon Inflation (Class II - Special Controls, product code MAV).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 10, 1995, 202 days after receiving the submission on July 23, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K943597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1994 |
| Decision Date | February 10, 1995 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MAV — Syringe, Balloon Inflation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |