FDA 510(k) Application Details - K965137

Device Classification Name	Valvulotome   More FDA Info for this Device
510(K) Number	K965137
Device Name	Valvulotome
Applicant	BAXTER EDWARDS 17221 RED HILL AVE. IRVINE, CA 92614-5627 US Other 510(k) Applications for this Company
Contact	PAULA TORRIANNI Other 510(k) Applications for this Contact
Regulation Number	870.4885   More FDA Info for this Regulation Number
Classification Product Code	MGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/1996
Decision Date	06/04/1997
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