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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K182914
Device Name MC3 Vascular Access Kit 21030
Applicant
Mc3 Incorporated
2555 Bishop Cir. W
Dexter,  MI  48130
Applicant Contact Adam Viitala
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number870.1310
Classification Product Code
DRE  
Date Received10/18/2018
Decision Date 10/29/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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