INOUE BALLOON A— 510(k) K220881

Substantially Equivalent

Toray Industries, Inc.

FDA 510(k) clearance K220881 for INOUE BALLOON A, Substantially Equivalent on 2022-12-18. Applicant: Toray Industries, Inc..

Clearance details

Applicant: Toray Industries, Inc.
Product code: Code OZT
Advisory panel: Cardiovascular
Date received: 2022-03-25
Decision date: 2022-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chuo-Ku, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code OZT

product code OZT

Death: 20
Other: 2
Total: 22

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.