FDA 510(k) Application Details - K243529

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K243529
Device Name	Set, Administration, Intravascular
Applicant	Baxter Healthcare Corporation 25212 W IL Route 120 Round Lake, IL 60073 US Other 510(k) Applications for this Company
Contact	Meaghan Bonn 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	11/14/2024
Decision Date	03/14/2025
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	N
Expedited Review