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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary, Internal Use Hemostatic
510(k) Number K243553
Device Name QuikClot Control+ Hemostatic Device
Applicant
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact Jane Doll
Correspondent
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact Jane Doll
Regulation Number878.4454
Classification Product Code
POD  
Subsequent Product Code
QSY  
Date Received11/18/2024
Decision Date 03/18/2025
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 No
Predetermined Change
Control Plan Authorized		 No
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