FDA 510(k) Application Details - K083763

Device Classification Name	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days   More FDA Info for this Device
510(K) Number	K083763
Device Name	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant	R4 VASCULAR, INC. 7550 MERIDIAN CIR. N MAPLE GROVE, MN 55369 US Other 510(k) Applications for this Company
Contact	LAURIE LEWANDOWSKI 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	12/18/2008
Decision Date	03/16/2009
Decision	SESE - SUBST EQUIV
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