FDA 510(k) Application Details - K131998

Device Classification Name	More FDA Info for this Device
510(K) Number	K131998
Device Name	ASPIRE RX-LP6 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 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	06/28/2013
Decision Date	11/26/2013
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