FDA 510(k) Application Details - K113757

Device Classification Name	More FDA Info for this Device
510(K) Number	K113757
Device Name	ASPIRE MAX ASPIRATION CATHETER
Applicant	CONTROL MEDICAL TECHNOLOGY, LLC 136 HEBER AVENUE, SUITE 101, PO BOX 681013 PARK CITY, UT 84068 US Other 510(k) Applications for this Company
Contact	SHAWN P FOJTIK Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2011
Decision Date	02/22/2012
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