ValvuloPro Valvuloplasty Balloon Catheter
FDA 510(k) K240967 · Dongguan TT Medical, Inc.
510(k) numberK240967
Submission
- Device name
- ValvuloPro Valvuloplasty Balloon Catheter
- Applicant
- Dongguan TT Medical, Inc.
Dongguan, CN - Received
- April 9, 2024
- Decision date
- July 31, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OZT – Balloon Aortic Valvuloplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1255
- Specialty
- Cardiovascular
A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Other 510(k)s with product code OZT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253855 | KardiaPSI Balloon CatheterOZT · Traditional | Intervention Tech, Inc. ; dba Corvention | 05/06/2026SE |
| K260437 | Valvuloplasty Balloon Catheter (ValvuloPro)OZT · Special | Dongguan TT Medical, Inc. | 03/20/2026SE |
| K241562 | OutFlo Aortic Valve Dilatation Balloon CatheterOZT · Traditional | Disa Medinotec | 03/11/2025SE |
| K231814 | ValvuloPro Valvuloplasty Balloon CatheterOZT · Traditional | Dongguan TT Medical, Inc. | 10/12/2023SE |
| K220881 | Inoue Balloon aOZT · Traditional | Toray Industries, Inc. | 12/18/2022SE |
| K172932 | True Flow Valvuloplasty Perfusion CatheterOZT · Traditional | C.R. Bard, Inc. | 12/13/2017SE |
| K152613 | True Flow Valvuloplasty Perfusion CatheterOZT · Traditional | C.R. Bard, Inc. | 01/19/2016SE |
| K152150 | V8 Balloon Aortic Valvuloplasty CatheterOZT · Traditional | Intervalve, Inc. | 12/18/2015SE |
| K150667 | True Dilatation Balloon Valvuloplasty CatheterOZT · Traditional | C.R. Bard, Inc. | 06/17/2015SE |
| K142083 | True Flow Valvuloplasty Perfusion CatheterOZT · Traditional | C.R. Bard, Inc. | 04/17/2015SE |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260437 | Valvuloplasty Balloon Catheter (ValvuloPro)OZT · Special | 03/20/2026SE |
| K231814 | ValvuloPro Valvuloplasty Balloon CatheterOZT · Traditional | 10/12/2023SE |
| K230374 | Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon…LOX · Traditional | 06/29/2023SE |
| K222663 | MultiStage Balloon Dilatation CatheterFGE · Traditional | 03/09/2023SE |
| K222187 | Multistage Balloon Dilatation CatheterKTI · Traditional | 03/01/2023SE |
Questions and answers
When was ValvuloPro Valvuloplasty Balloon Catheter cleared by the FDA?
ValvuloPro Valvuloplasty Balloon Catheter (K240967) received a 510(k) decision of Substantially Equivalent on July 31, 2024, 113 days after the submission was received.
What is the product code of K240967?
The FDA product code is OZT – Balloon Aortic Valvuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.1255.