Matreneu Percutaneous Balloon Compression Kit— 510(k) K220920

Name: FDA 510(k) clearance K220920
Creator: U.S. Food and Drug Administration
Published: 2022-09-07

Substantially Equivalent

Shenzhen Shineyard Medical Device Co. , Ltd.

FDA 510(k) clearance K220920 for Matreneu Percutaneous Balloon Compression Kit, Substantially Equivalent on 2022-09-07. Applicant: Shenzhen Shineyard Medical Device Co. , Ltd.. Device class: 1.

Clearance details

Applicant: Shenzhen Shineyard Medical Device Co. , Ltd.
Product code: Code HAO
Device class: Class 1
Regulation: 21 CFR 882.4535
Advisory panel: Neurology
Date received: 2022-03-30
Decision date: 2022-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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