Cleared Traditional

SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)

K133894 · Terumo Europe N.V. · General Hospital
Mar 2014
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K133894 is an FDA 510(k) clearance for the SURFLO WINGED INFUSION SET WITH FILTER & 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 March 18, 2014, 88 days after receiving the submission on December 20, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K133894 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2013
Decision Date March 18, 2014
Days to Decision 88 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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