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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 K192366
Device Name Intravascular Extension Sets and Accessories
Applicant
Baxter Healthcare Corporation
32650 N. Wilson Road
Round Lake,  IL  60073
Applicant Contact Gary Chumbimune
Correspondent
Baxter Healthcare Corporation
32650 N. Wilson Road
Round Lake,  IL  60073
Correspondent Contact Gary Chumbimune
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FPB  
Date Received08/30/2019
Decision Date 07/20/2020
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
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