FDA 510(k) Application Details - K113277

Device Classification Name	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days   More FDA Info for this Device
510(K) Number	K113277
Device Name	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant	ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. READING, PA 19605 US Other 510(k) Applications for this Company
Contact	TRACY MADDOCK 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	11/07/2011
Decision Date	06/21/2012
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