The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Viceroy Inflation Device.
| Device ID | K040138 |
| 510k Number | K040138 |
| Device Name: | VICEROY INFLATION DEVICE |
| Classification | Syringe, Balloon Inflation |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | John Nicholson |
| Correspondent | J.a. Van Vugt KEMA QUALITY B.V. P.O. BOX 5185 6802 ED ARNHEM Arnhem, NL |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-01-22 |
| Decision Date | 2004-02-13 |
| Summary: | summary |