FDA product code OZT: Balloon Aortic Valvuloplasty
OZT is the FDA product code for balloon aortic valvuloplasty. It is a Class II device, regulated under 21 CFR 870.1255 and reviewed by the Cardiovascular panel. FDA has cleared 21 510(k) submissions under OZT, 6 in the last five years, from 11 different applicants. The average 510(k) review took 123 days (median 113); 164 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 2 recalls for OZT devices.
Definition
A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Classification
| Field | Value |
|---|---|
| Device name | Balloon Aortic Valvuloplasty |
| Device class | Class II |
| Regulation | 21 CFR 870.1255 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for OZT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 78 |
| 2022 | 1 | 268 |
| 2023 | 1 | 113 |
| 2024 | 1 | 113 |
| 2025 | 1 | 284 |
| 2026 | 2 | 96 |
Compare with all 510(k) review times · Search every OZT clearance
Top OZT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 5 | 2017-12-13 |
| Intervalve, Inc. | 5 | 2015-12-18 |
| Dongguan TT Medical, Inc. | 3 | 2026-03-20 |
| Intervention Tech, Inc. ; dba Corvention | 1 | 2026-05-06 |
| Disa Medinotec | 1 | 2025-03-11 |
6 more applicants have OZT clearances. See the full list in Caduvo.
Most recent OZT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253855 | Intervention Tech, Inc. ; dba Corvention | KardiaPSI Balloon Catheter | 2026-05-06 | 154 |
| K260437 | Dongguan TT Medical, Inc. | Valvuloplasty Balloon Catheter (ValvuloPro) | 2026-03-20 | 37 |
| K241562 | Disa Medinotec | OutFlo Aortic Valve Dilatation Balloon Catheter | 2025-03-11 | 284 |
| K240967 | Dongguan TT Medical, Inc. | ValvuloPro Valvuloplasty Balloon Catheter | 2024-07-31 | 113 |
| K231814 | Dongguan TT Medical, Inc. | ValvuloPro Valvuloplasty Balloon Catheter | 2023-10-12 | 113 |
Recalls for OZT devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-03-14.
Frequently asked questions
What is FDA product code OZT?
OZT is the FDA product code for balloon aortic valvuloplasty. It is a Class II device, regulated under 21 CFR 870.1255 and reviewed by the Cardiovascular panel.
What device class is OZT?
Class II, regulation 21 CFR 870.1255. Typical premarket route: 510(k).
How long does a 510(k) take for product code OZT?
Across 21 cleared submissions the average was 123 days from receipt to decision (median 113).
Which companies have the most OZT clearances?
C.R. Bard, Inc. (5); Intervalve, Inc. (5); Dongguan TT Medical, Inc. (3); Intervention Tech, Inc. ; dba Corvention (1); Disa Medinotec (1).
Have OZT devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2014-03-14.
Next steps
- Run an FDA pathway report with predicate devices for product code OZT
- Run a recall and safety report across every OZT manufacturer
- Watch product code OZT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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