FDA 510(k) Application Details - K973477

Device Classification Name	Catheter, Embolectomy   More FDA Info for this Device
510(K) Number	K973477
Device Name	Catheter, Embolectomy
Applicant	SUNSCOPE INTL., INC. 20250 ACACIA ST., SUITE 115 NEWPORT BEACH, CA 92660 US Other 510(k) Applications for this Company
Contact	JOHN SHULZE 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	09/15/1997
Decision Date	09/04/1998
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