Syringe, Balloon Inflation, Exempt
FDA product code PTM · Class II (moderate risk) · 21 CFR 870.1650 · Cardiovascular
This product code is the class II exempt counterpart of MAV, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
0510(k) clearances
0PMA approvals
7recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1123-2026 Class II | Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers:…Inflation device handle may detach from the syringe during procedure. | Merit Medical Systems, Inc. | 12/04/2025Open, Classified |
| Z-2533-2025 Class II | Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011…The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the… | Boston Scientific Corporation | 08/05/2025Open, Classified |
| Z-0072-2025 Class II | basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C…Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | Merit Medical Systems, Inc. | 08/19/2024Open, Classified |
| Z-0071-2025 Class II | basixSKY Inflation Device, REF: SKY1802Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | Merit Medical Systems, Inc. | 08/19/2024Open, Classified |
| Z-0068-2025 Class II | BlueFIRE Inflation Device, REF: IN10140Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | Merit Medical Systems, Inc. | 08/19/2024Open, Classified |
| Z-0065-2025 Class II | basixTOUCH Inflation Device, REF: IN8140/AInflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | Merit Medical Systems, Inc. | 08/19/2024Open, Classified |
| Z-2166-2021 Class II | basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and…Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn. | Merit Medical Systems, Inc. | 06/10/2021Terminated |