K220881 is an FDA 510(k) clearance for the INOUE BALLOON A. This device is classified as a Balloon Aortic Valvuloplasty (Class II - Special Controls, product code OZT).
Submitted by Toray Industries, Inc. (Chuo-Ku, JP). The FDA issued a Cleared decision on December 18, 2022, 268 days after receiving the submission on March 25, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1255. A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve..
| 510(k) Number | K220881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2022 |
| Decision Date | December 18, 2022 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | OZT - Balloon Aortic Valvuloplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1255 |
| Definition | A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve. |