Cleared Traditional

INOUE BALLOON A

K220881 · Toray Industries, Inc. · Cardiovascular

Dec 2022

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K220881 is an FDA 510(k) clearance for the INOUE BALLOON A, 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 review panel. Regulated under 21 CFR 870.1255.

Submission Details

510(k) Number	K220881 FDA.gov
FDA Decision	Cleared 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

Device Classification

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.