FDA 510(k) Application Details - K000430

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K000430
Device Name	Oxygenator, Cardiopulmonary Bypass
Applicant	MEDTRONIC VASCULAR 4633 EAST LA PALMA AVE. ANAHEIM, CA 92807 US Other 510(k) Applications for this Company
Contact	DEBRA KRIDNER Other 510(k) Applications for this Contact
Regulation Number	870.4350   More FDA Info for this Regulation Number
Classification Product Code	DTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/09/2000
Decision Date	02/25/2000
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