FDA 510(k) Application Details - K082519

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K082519
Device Name	Catheter, Continuous Flush
Applicant	TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 US Other 510(k) Applications for this Company
Contact	MARK UNTERREINER Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2008
Decision Date	09/26/2008
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	Y
Expedited Review