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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 K120164
Device Name PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
Applicant
Angioslide, Ltd.
11925 W I-70 Frontage Rd.
North Suite 900
Wheat Ridge,  CO  80033
Applicant Contact CLAY ANSELMO
Correspondent
Angioslide, Ltd.
11925 W I-70 Frontage Rd.
North Suite 900
Wheat Ridge,  CO  80033
Correspondent Contact CLAY ANSELMO
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received01/19/2012
Decision Date 06/08/2012
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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