Cleared Traditional

SURSHIELD SAFETY WINGED BLOOD COLLECTION SET

K031279 · Terumo Medical Products Hangzhou Co., Ltd. · General Hospital
May 2003
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K031279 is an FDA 510(k) clearance for the SURSHIELD SAFETY WINGED BLOOD COLLECTION SET, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Terumo Medical Products Hangzhou Co., Ltd. (Elkton, US). The FDA issued a Cleared decision on May 30, 2003, 38 days after receiving the submission on April 22, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K031279 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2003
Decision Date May 30, 2003
Days to Decision 38 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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