Panels › Cardiovascular › Product code PTM · Class 2
Syringe, Balloon Inflation, Exempt
Regulation 870.1650
0510(k)s in 12 months (0 all time)
1recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in PTM
| Company | 510(k)s | Recalls |
|---|---|---|
| Merit Medical Systems, Inc. | 0 | 6 |
| Boston Scientific Corporation | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2026 | Merit Medical Systems, Inc. Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL
Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330 Open, Classified |
PTM | None listed |
| Sep 5, 2025 | Boston Scientific Corporation Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN):
1. H74904526011;
2. H74904526052;
3. M0067101140;
4. M001151050;
5. M001151062;
6. M00566670.
(Interventional Cardiology, Open, Classified |
PTM | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C Open, Classified |
PTM | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. basixSKY Inflation Device, REF: SKY1802 Open, Classified |
PTM | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. BlueFIRE Inflation Device, REF: IN10140 Open, Classified |
PTM | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. basixTOUCH Inflation Device, REF: IN8140/A Open, Classified |
PTM | None listed |
| Jun 10, 2021 | Merit Medical Systems, Inc. basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon. Terminated |
PTM | None listed |
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