Inoue Balloon a
FDA 510(k) K220881 · Toray Industries, Inc.
510(k) numberK220881
Submission
- Device name
- Inoue Balloon a
- Applicant
- Toray Industries, Inc.
Chuo-Ku, JP - Received
- March 25, 2022
- Decision date
- December 18, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K240967 | ValvuloPro Valvuloplasty Balloon CatheterOZT · Special | Dongguan TT Medical, Inc. | 07/31/2024SE |
| K231814 | ValvuloPro Valvuloplasty Balloon CatheterOZT · Traditional | Dongguan TT Medical, Inc. | 10/12/2023SE |
| 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 |
Questions and answers
When was Inoue Balloon a cleared by the FDA?
Inoue Balloon a (K220881) received a 510(k) decision of Substantially Equivalent on December 18, 2022, 268 days after the submission was received.
What is the product code of K220881?
The FDA product code is OZT – Balloon Aortic Valvuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.1255.