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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 K182167
Device Name The ICHOR Panacea Vascular Embolectomy Catheter System
Applicant
Ichor Vascular, Inc.
2865 N Reynolds Rd. Suite 220a
Toledo,  OH  43615
Applicant Contact Jeff Blair
Correspondent
NAMSA
400 Highway 169 S Suite 500
Minneapolis,  MN  55426
Correspondent Contact Angela Mallery
Regulation Number870.5150
Classification Product Code
QEW  
Date Received08/10/2018
Decision Date 12/21/2018
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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