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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 K182232
Device Name Octane Mechanical Thrombectomy System
Applicant
Vascular Solutions, Inc.
6401 Sycamore Ct N
Maple Grove,  MN  55369
Applicant Contact Iroquois Ledbeter
Correspondent
Vascular Solutions, Inc.
6401 Sycamore Ct N
Maple Grove,  MN  55369
Correspondent Contact Iroquois Ledbeter
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
Date Received08/17/2018
Decision Date 09/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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