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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter,intravascular,therapeutic,short-term less than 30 days
510(K) Number K122544
Device Name TERUMO SURFLASH SAFETY I.V. CATHETER
Applicant
TERUMO CORPORATION
1727-1, tsuijiarai, showa-cho
nakakoma-gun
yamanashi, 
Contact sandi hartka
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/21/2012
Decision Date 09/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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