FDA 510(k) Application Details - K961992

Device Classification Name	Catheter, Embolectomy   More FDA Info for this Device
510(K) Number	K961992
Device Name	Catheter, Embolectomy
Applicant	COOK PACEMAKER CORP. ROUTE 66 RIVER RD. P.O. BOX 529 LEECHBURG, PA 15656 US Other 510(k) Applications for this Company
Contact	NEAL E FEARNOT Other 510(k) Applications for this Contact
Regulation Number	870.5150   More FDA Info for this Regulation Number
Classification Product Code	DXE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/1996
Decision Date	12/27/1996
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