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FDA 510(k)

FineCross M3

K-Number: K203521 · 2021-03-03

ApplicantAshitaka Factory of Terumo Corporation
Decision Date2021-03-03
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FineCross M3 is the device name listed in this FDA 510(k) record. The listed applicant is Ashitaka Factory of Terumo Corporation. It received FDA 510(k) clearance on 2021-03-03 under 510(k) number K203521. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FineCross M3?

FineCross M3 is a medical device that received FDA 510(k) clearance on 2021-03-03. The listed applicant is Ashitaka Factory of Terumo Corporation. The 510(k) number is K203521.

When did FineCross M3 receive FDA 510(k) clearance?

FineCross M3 received FDA 510(k) clearance on 2021-03-03, under 510(k) number K203521.

Who is the listed applicant for FineCross M3?

The FDA 510(k) record lists Ashitaka Factory of Terumo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FineCross M3?

The FDA product code for FineCross M3 is DQY.

Other records listing Ashitaka Factory of Terumo Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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