Data / Medical devices / Balloon Aortic Valvuloplasty
Balloon Aortic Valvuloplasty (OZT): 15 FDA-registered makers in 6 countries
15 establishments in 6 countries are registered with the FDA to make Balloon Aortic Valvuloplasty (product code OZT, Class 2, 21 CFR 870.1255). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 22 510(k) clearances under this code, the latest on May 6, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OZT
- Device class
- 2
- Regulation
- 870.1255
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Japan | 2 |
| China | 1 |
| Canada | 1 |
| South Africa | 1 |
| Mexico | 1 |
Makers of Balloon Aortic Valvuloplasty
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Complaint file establishment, Specification developer | 3 | December 13, 2017 | 0 | 0 | 0 | api.fda.gov |
| Dongguan TT Medical, Inc. | Dongguan Guangdong, China | Manufacturer | 3 | March 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences LLC | Irvine, CA, United States | Manufacturer | 2 | October 29, 2014 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences LLC | Draper, UT, United States | Manufacturer | 2 | October 29, 2014 | 0 | 0 | 0 | api.fda.gov |
| Numed Canada, Inc. | CORNWALL Ontario, Canada | Manufacturer | 2 | October 4, 2012 | 0 | 0 | 0 | api.fda.gov |
| Numed, Inc. | Hopkinton, NY, United States | Manufacturer | 2 | October 4, 2012 | 0 | 0 | 0 | api.fda.gov |
| Disa Medinotec (pty) Ltd | Northriding, Johannesburg Gauteng, South Africa | Manufacturer | 1 | March 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Intervention Tech, Inc | Flagstaff, AZ, United States | Complaint file establishment, Specification developer | 1 | May 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Toray Industries, Inc. | CHUO-KU Tokyo, Japan | Complaint file establishment, Specification developer | 1 | December 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Toray Industries, Inc. Seta Plant | OTSU Shiga, Japan | Manufacturer | 1 | December 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Bard Reynosa S.A. De C.V. | REYNOSA Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics Fmi | Athens, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Poba Medical | Flagstaff, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Springboard Manufacturing | Rancho Cordova, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.