Cleared Traditional

Radial Artery Compression Tourniquets

K222182 · Beijing Demax Medical Technology Co.,Ltd · Cardiovascular
Jan 2023
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K222182 is an FDA 510(k) clearance for the Radial Artery Compression Tourniquets, a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Beijing Demax Medical Technology Co.,Ltd (Beijing, CN). The FDA issued a Cleared decision on January 4, 2023, 166 days after receiving the submission on July 22, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K222182 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2022
Decision Date January 04, 2023
Days to Decision 166 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DXC — Clamp, Vascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4450

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