The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Basixtouch40 Inflation Syringe.
| Device ID | K153672 |
| 510k Number | K153672 |
| Device Name: | BasixTOUCH40 Inflation Syringe |
| Classification | Syringe, Balloon Inflation |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Dan W. Lindsay |
| Correspondent | Dan W. Lindsay MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-01-20 |
| Summary: | summary |