The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Monarch Ap(tm).
| Device ID | K943597 |
| 510k Number | K943597 |
| Device Name: | MONARCH AP(TM) |
| Classification | Syringe, Balloon Inflation |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Dennis Reigle |
| Correspondent | Dennis Reigle MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-23 |
| Decision Date | 1995-02-10 |