FDA 510(k) Application Details - K222437

Device Classification Name	Guide, Wire, Catheter, Neurovasculature   More FDA Info for this Device
510(K) Number	K222437
Device Name	Guide, Wire, Catheter, Neurovasculature
Applicant	Scientia Vascular Inc 3487 West 2100 South Suite 100 West Valley City, UT 84119 US Other 510(k) Applications for this Company
Contact	Max Alfonso 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	08/12/2022
Decision Date	01/26/2023
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
Expedited Review