FDA 510(k) Application Details - K041849

Device Classification Name	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days   More FDA Info for this Device
510(K) Number	K041849
Device Name	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant	COOK, INC. 750 DANIELS WAY P.O. BOX 489 BLOOMINGTON, IN 47402 US Other 510(k) Applications for this Company
Contact	EARL E KNIGHT III Other 510(k) Applications for this Contact
Regulation Number	880.5970   More FDA Info for this Regulation Number
Classification Product Code	LJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/08/2004
Decision Date	07/21/2005
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review