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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 K083784
Device Name PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,
Applicant
Vascular Solutions, Inc.
6464 Sycamore Court
Minneapolis,  MN  55369
Applicant Contact CHARMAINE SUTTON
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Court
Minneapolis,  MN  55369
Correspondent Contact CHARMAINE SUTTON
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received12/19/2008
Decision Date 03/30/2009
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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