FDA 510(k) Application Details - K061958

Device Classification Name	More FDA Info for this Device
510(K) Number	K061958
Device Name	MEDTRONIC EXPORT XT CATHETER
Applicant	MEDTRONIC VASCULAR 37A CHERRY HILL DR. DANVERS, MA 01923 US Other 510(k) Applications for this Company
Contact	KAREN A BROZOWSKI 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	07/11/2006
Decision Date	09/05/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review