FDA 510(k) Application Details - K092425

Device Classification Name	More FDA Info for this Device
510(K) Number	K092425
Device Name	REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
Applicant	ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. PHOENIX, AZ 85044 US Other 510(k) Applications for this Company
Contact	AMANDA BABCOCK Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2009
Decision Date	10/21/2009
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