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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 K143093
Device Name 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)
Applicant
Hotspur Technologies, Inc.,
880 Maude Ave., Suite A
Mountain View,  CA  94043
Applicant Contact Eric Ankerud, JD
Correspondent
Hotspur Technologies, Inc.,
880 Maude Ave., Suite A
Mountain View,  CA  94043
Correspondent Contact Eric Ankerud, JD
Regulation Number870.1250
Classification Product Code
LIT  
Date Received10/28/2014
Decision Date 06/24/2015
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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