Cleared Traditional

SURFLO WINGED INFUSION SET

K070362 · Terumo Europe N.V. · General Hospital
May 2007
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K070362 is an FDA 510(k) clearance for the SURFLO WINGED INFUSION SET, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on May 7, 2007, 89 days after receiving the submission on February 7, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K070362 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2007
Decision Date May 07, 2007
Days to Decision 89 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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