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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K142300
Device Name Arrow GPSCath Balloon Dialation Catheter (150 cm)
Applicant
HOTSPUR TECHNOLOGIES, INC.,
A SUBSIDIARY OF TELEFLEX MEDICAL, INC.
880 MAUDE AVENUE, SUITE A
MOUNTAIN VIEW,  CA  94043
Applicant Contact ERICK ANKERUD
Correspondent
HOTSPUR TECHNOLOGIES, INC.,
A SUBSIDIARY OF TELEFLEX MEDICAL, INC.
880 MAUDE AVENUE, SUITE A
MOUNTAIN VIEW,  CA  94043
Correspondent Contact ERICK ANKERUD
Regulation Number870.1250
Classification Product Code
LIT  
Date Received08/18/2014
Decision Date 09/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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