FDA 510(k) Application Details - K243404

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K243404
Device Name	Set, I.V. Fluid Transfer
Applicant	Takeda Pharmaceuticals 500 Kendall Street Cambridge, MA 02142 US Other 510(k) Applications for this Company
Contact	Louwanna Wilson Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	LHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2024
Decision Date	07/18/2025
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