FDA 510(k) Application Details - K051917

Device Classification Name	More FDA Info for this Device
510(K) Number	K051917
Device Name	DIVER C.E. CATHETER
Applicant	INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. 4600 Nathan Lane North Plymouth, MN 55442 US Other 510(k) Applications for this Company
Contact	STEPHANIE K ISGRIGG ROBINSON 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	07/15/2005
Decision Date	08/08/2005
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