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FDA 510(k)

Corin BiPolar-i

K-Number: K183114 · 2019-06-05

ApplicantCorin U.S.A. Limited
Decision Date2019-06-05
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Corin BiPolar-i is the device name listed in this FDA 510(k) record. The listed applicant is Corin U.S.A. Limited. It received FDA 510(k) clearance on 2019-06-05 under 510(k) number K183114. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Corin BiPolar-i?

Corin BiPolar-i is a medical device that received FDA 510(k) clearance on 2019-06-05. The listed applicant is Corin U.S.A. Limited. The 510(k) number is K183114.

When did Corin BiPolar-i receive FDA 510(k) clearance?

Corin BiPolar-i received FDA 510(k) clearance on 2019-06-05, under 510(k) number K183114.

Who is the listed applicant for Corin BiPolar-i?

The FDA 510(k) record lists Corin U.S.A. Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Corin BiPolar-i?

The FDA product code for Corin BiPolar-i is KWY.

Other records listing Corin U.S.A. Limited as applicant

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Related Devices (Code: KWY)

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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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