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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 K090364
Device Name EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE
Applicant
Angioslide, Ltd.
18905 Celebrity Lane
Sandy Spring,  MD  20860
Applicant Contact ELISA HARVEY
Correspondent
Angioslide, Ltd.
18905 Celebrity Lane
Sandy Spring,  MD  20860
Correspondent Contact ELISA HARVEY
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received02/13/2009
Decision Date 03/23/2010
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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