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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Embolectomy
510(k) Number K100842
Device Name PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM
Applicant
Hotspur Technologies
880 Maude Ave., Suite A
Mountain View,  CA  94043
Applicant Contact Eric Ankerud
Correspondent
Hotspur Technologies
880 Maude Ave., Suite A
Mountain View,  CA  94043
Correspondent Contact Eric Ankerud
Regulation Number870.5150
Classification Product Code
DXE  
Subsequent Product Code
LIT  
Date Received03/25/2010
Decision Date 07/12/2010
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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