Cleared Traditional

Matreneu Percutaneous Balloon Compression Kit

K220920 · Shenzhen Shineyard Medical Device Co. , Ltd. · Neurology
Sep 2022
Decision
161d
Days
Class 1
Risk

About This 510(k) Submission

K220920 is an FDA 510(k) clearance for the Matreneu Percutaneous Balloon Compression Kit, a Instrument, Surgical, Non-powered (Class I — General Controls, product code HAO), submitted by Shenzhen Shineyard Medical Device Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 7, 2022, 161 days after receiving the submission on March 30, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4535.

Submission Details

510(k) Number K220920 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2022
Decision Date September 07, 2022
Days to Decision 161 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAO — Instrument, Surgical, Non-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.4535

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