Cleared Special

SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)

K072894 · Terumo Europe N.V. · General Hospital
Nov 2007
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K072894 is an FDA 510(k) clearance for the SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), 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 November 6, 2007, 26 days after receiving the submission on October 11, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K072894 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 2007
Decision Date November 06, 2007
Days to Decision 26 days
Submission Type Special
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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