FDA 510(k) Application Details - K243756

Device Classification Name	Guide, Wire, Catheter, Neurovasculature   More FDA Info for this Device
510(K) Number	K243756
Device Name	Guide, Wire, Catheter, Neurovasculature
Applicant	Arbor Endovascular, LLC 2345 Bering Drive San Jose, CA 95131 US Other 510(k) Applications for this Company
Contact	Kim Otto Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	MOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2024
Decision Date	07/17/2025
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
Expedited Review