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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 K173266
Device Name Octane aspiration system
Applicant
Vascular Solutions, Inc.
6464 Sycamore Court N
Maple Grove,  MN  55369
Applicant Contact Becky Astrup
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Court N
Maple Grove,  MN  55369
Correspondent Contact Becky Astrup
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
Date Received10/11/2017
Decision Date 12/01/2017
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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