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FDA 510(k)

INOUE BALLOON A

K-Number: K220881 · 2022-12-18

ApplicantToray Industries, Inc.
Decision Date2022-12-18
Product CodeOZT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INOUE BALLOON A is a medical device manufactured by Toray Industries, Inc.. It received FDA 510(k) clearance on 2022-12-18 under approval number K220881. The device is classified under product code OZT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INOUE BALLOON A?

INOUE BALLOON A is a medical device that received FDA 510(k) clearance on 2022-12-18. It is manufactured by Toray Industries, Inc.. The 510(k) number is K220881.

When was INOUE BALLOON A approved by the FDA?

INOUE BALLOON A received FDA 510(k) clearance on 2022-12-18, under approval number K220881.

What company makes INOUE BALLOON A?

INOUE BALLOON A is manufactured by Toray Industries, Inc..

What is the FDA product code for INOUE BALLOON A?

The FDA product code for INOUE BALLOON A is OZT.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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