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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K133894
Device Name SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
Applicant
TERUMO EUROPE N.V.
INTERLEUVENLAAN 40
LEUVEN,  BE 3001
Applicant Contact M.J. AERTS
Correspondent
TERUMO EUROPE N.V.
INTERLEUVENLAAN 40
LEUVEN,  BE 3001
Correspondent Contact M.J. AERTS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/20/2013
Decision Date 03/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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