FDA 510(k) Application Details - K210601

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K210601
Device Name	Catheter, Percutaneous
Applicant	Scientia Vascular LLC 3487 West 2100 South Suite 100 West Valley City, UT 84119 US Other 510(k) Applications for this Company
Contact	Amy McManus 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	03/01/2021
Decision Date	04/28/2021
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	Y
Expedited Review