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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 the device name listed in this FDA 510(k) record. The listed applicant is Toray Industries, Inc.. It received FDA 510(k) clearance on 2022-12-18 under 510(k) 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. The listed applicant is Toray Industries, Inc.. The 510(k) number is K220881.

When did INOUE BALLOON A receive FDA 510(k) clearance?

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

Who is the listed applicant for INOUE BALLOON A?

The FDA 510(k) record lists Toray Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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