FDA 510(k) Application Details - K243938

Device Classification Name	Guide, Wire, Catheter, Neurovasculature   More FDA Info for this Device
510(K) Number	K243938
Device Name	Guide, Wire, Catheter, Neurovasculature
Applicant	Scientia Vascular Inc 2460 South 3270 West West Valley City, UT 84119 US Other 510(k) Applications for this Company
Contact	Bret Draper 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	12/20/2024
Decision Date	04/01/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review