FDA 510(k) Application Details - K970762

Device Classification Name	Catheter, Embolectomy   More FDA Info for this Device
510(K) Number	K970762
Device Name	Catheter, Embolectomy
Applicant	APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 LAGUNA HILLS, CA 92653 US Other 510(k) Applications for this Company
Contact	HOWARD V ROWE 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	03/03/1997
Decision Date	03/28/1997
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