Cleared Traditional

Safety Winged Blood Collection Sets

K211293 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Jun 2021
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K211293 is an FDA 510(k) clearance for the Safety Winged Blood Collection Sets, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on June 25, 2021, 60 days after receiving the submission on April 26, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K211293 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2021
Decision Date June 25, 2021
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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