FDA 510(k) Application Details - K981359

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K981359
Device Name	Catheter, Percutaneous
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	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/1998
Decision Date	01/27/1999
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