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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K133853
FOIA Releasable 510(k) K133853
Device Name VIEWFLEX XTRA ICE CATHETER
Applicant
Irvine Biomedical, Inc., A St. Jude Medical Company
2375 Morse Ave.
Irvine,  CA  92614
Applicant Contact JENNIFER CORREA
Correspondent
Irvine Biomedical, Inc., A St. Jude Medical Company
2375 Morse Ave.
Irvine,  CA  92614
Correspondent Contact JENNIFER CORREA
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received12/19/2013
Decision Date 05/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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