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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K080806
Device Name ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608
Applicant
Possis Medical, Inc.
9055 Evergreen Blvd. NW
Minneapolis,  MN  55433
Applicant Contact MIKE BURNSIDE
Correspondent
Possis Medical, Inc.
9055 Evergreen Blvd. NW
Minneapolis,  MN  55433
Correspondent Contact MIKE BURNSIDE
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received03/21/2008
Decision Date 04/04/2008
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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