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FDA 510(k) Application Details - K180739
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K180739
Device Name
Set, Administration, Intravascular
Applicant
Baxter Healthcare Corporation
32650 N. Wilson Road
Round Lake, IL 60073 US
Other 510(k) Applications for this Company
Contact
Jeanette Licata
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/22/2018
Decision Date
05/28/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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