FDA 510(k) Application Details - K193119

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K193119
Device Name	Catheter, Percutaneous
Applicant	Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369 US Other 510(k) Applications for this Company
Contact	Iroquois Ledbeter 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	11/12/2019
Decision Date	06/29/2020
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