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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intravenous Catheter Force-Activated Separation Device.
510(k) Number K231957
Device Name SafeBreak® Vascular
Applicant
Lineus Medical
179 N. Church Ave., Suite 202
Fayetteville,  AZ  72701
Applicant Contact Vance Clement
Correspondent
MRC Global, LLC
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Dawn Norman
Regulation Number880.5220
Classification Product Code
QOI  
Date Received07/03/2023
Decision Date 09/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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