FDA 510(k) Application Details - K162467

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K162467
Device Name	Catheter, Percutaneous
Applicant	VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 US Other 510(k) Applications for this Company
Contact	LISA GALLATIN 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	09/02/2016
Decision Date	02/01/2017
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