FDA 510(k) Application Details - K192454

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K192454
Device Name	Wire, Guide, Catheter
Applicant	Vascular Solutions 6464 Sycamore Court North Minneapolis, MN 55369 US Other 510(k) Applications for this Company
Contact	Nancy Frame 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	09/09/2019
Decision Date	01/15/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review