FDA 510(k) Application Details - K232437

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K232437
Device Name	Catheter, Percutaneous
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	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2023
Decision Date	10/13/2023
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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