FDA 510(k) Application Details - K123311

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K123311
Device Name	Catheter, Percutaneous
Applicant	QXMEDICAL, LLC 1843 Buerkle Rd White Bear Lake, MN 55110 US Other 510(k) Applications for this Company
Contact	FERNANDO DI CAPRIO 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	10/25/2012
Decision Date	01/14/2013
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	Y
Expedited Review