The following data is part of a premarket notification filed by Merit Medical Ireland, Ltd. with the FDA for Basixconpak Analog Inflation Syringe.
| Device ID | K122321 |
| 510k Number | K122321 |
| Device Name: | BASIXCONPAK ANALOG INFLATION SYRINGE |
| Classification | Syringe, Balloon Inflation |
| Applicant | MERIT MEDICAL IRELAND, LTD. 1600 WEST MERIT PARKWAY South Jordan, UT 84095 |
| Contact | Stephanie Erskine |
| Correspondent | Stephanie Erskine MERIT MEDICAL IRELAND, LTD. 1600 WEST MERIT PARKWAY 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 | 2012-08-01 |
| Decision Date | 2012-12-19 |
| Summary: | summary |