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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K241058
Device Name Lyka® PORT Needle Free Access Device (4170Y)
Applicant
Quest Medical, Inc.
1 Allentown Pkwy.
Allen,  TX  75002
Applicant Contact Stephanie Edugie Ajayi
Correspondent
Quest Medical, Inc.
1 Allentown Pkwy.
Allen,  TX  75002
Correspondent Contact Stephanie Edugie Ajayi
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/18/2024
Decision Date 12/18/2024
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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