FDA 510(k) Application Details - K140557

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K140557
Device Name	Catheter, Percutaneous
Applicant	MIVI, LLC 10900 73RD AVE NE, SUITE 150 MAPLE GROVE, MN 55369 US Other 510(k) Applications for this Company
Contact	MICHELLE STRAIGHT 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	03/05/2014
Decision Date	09/18/2014
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