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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K212258
Device Name Medline Cardiovascular Procedure Kit
Applicant
Medline Industries, Inc.
Three Lakes Dr.
Northfiled,  IL  60093
Applicant Contact Stephanie Augsburg
Correspondent
Medline Industries, Inc.
Three Lakes Dr.
Northfiled,  IL  60093
Correspondent Contact Claire Pigman
Regulation Number878.4370
Classification Product Code
LRO  
Date Received07/20/2021
Decision Date 12/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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