FDA 510(k) Application Details - K992051

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K992051
Device Name	Catheter, Intravascular, Diagnostic
Applicant	TERUMO MEDICAL CORP. 125 BLUE BALL RD. ELKTON, MD 21921 US Other 510(k) Applications for this Company
Contact	YUK-TING LEWIS Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/18/1999
Decision Date	08/10/1999
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