FDA 510(k) Application Details - K013363

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K013363
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	TRANS VASCULAR INCORPORATED 1505-D ADAMS DR. MENLO PARK, CA 94925 US Other 510(k) Applications for this Company
Contact	STEVE JWANOUSKOS Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2001
Decision Date	04/02/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review