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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K130381
Device Name ANGIOJET ULTRA POWER PULSE KIT
Applicant
Medrad, Inc.
9055 Evergreen Blvd. NW
Minneapolis,  MN  55433 -8003
Applicant Contact AMRA RACIC
Correspondent
Medrad, Inc.
9055 Evergreen Blvd. NW
Minneapolis,  MN  55433 -8003
Correspondent Contact AMRA RACIC
Regulation Number870.5150
Classification Product Code
QEW  
Date Received02/14/2013
Decision Date 07/29/2013
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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