FDA 510(k) Application Details - K223139

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K223139
Device Name	Catheter, Continuous Flush
Applicant	Wallaby Medical 22901 Mill Creek Drive Laguna Hills, CA 92653 US Other 510(k) Applications for this Company
Contact	Joseph Tang Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/04/2022
Decision Date	04/25/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
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