FDA 510(k) Application Details - K201760

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K201760
Device Name	Wire, Guide, Catheter
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	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2020
Decision Date	07/29/2020
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
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