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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 K242339
Device Name Intravascular Extension Sets and Accessories
Applicant
Baxter Healthcare Corporation
25212 W. IL Route 120
Round Lake,  IL  60073
Applicant Contact Bernhard Bartmer
Correspondent
Baxter Healthcare Corporation
25212 W. IL Route 120
Round Lake,  IL  60073
Correspondent Contact Bernhard Bartmer
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FPB  
Date Received08/07/2024
Decision Date 02/28/2025
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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