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FDA 510(k)

Matreneu Percutaneous Balloon Compression Kit

K-Number: K220920 · 2022-09-07

ApplicantShenzhen Shineyard Medical Device Co. , Ltd.
Decision Date2022-09-07
Product CodeHAO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Matreneu Percutaneous Balloon Compression Kit is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Shineyard Medical Device Co. , Ltd.. It received FDA 510(k) clearance on 2022-09-07 under 510(k) number K220920. The device is classified under product code HAO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Matreneu Percutaneous Balloon Compression Kit?

Matreneu Percutaneous Balloon Compression Kit is a medical device that received FDA 510(k) clearance on 2022-09-07. The listed applicant is Shenzhen Shineyard Medical Device Co. , Ltd.. The 510(k) number is K220920.

When did Matreneu Percutaneous Balloon Compression Kit receive FDA 510(k) clearance?

Matreneu Percutaneous Balloon Compression Kit received FDA 510(k) clearance on 2022-09-07, under 510(k) number K220920.

Who is the listed applicant for Matreneu Percutaneous Balloon Compression Kit?

The FDA 510(k) record lists Shenzhen Shineyard Medical Device Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Matreneu Percutaneous Balloon Compression Kit?

The FDA product code for Matreneu Percutaneous Balloon Compression Kit is HAO.

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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