FDA 510(k) Application Details - K003006

Device Classification Name	Port & Catheter, Implanted, Subcutaneous, Intravascular   More FDA Info for this Device
510(K) Number	K003006
Device Name	Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant	ARROW INTL., INC. 2400 BERNVILLE RD. READING, PA 19605 US Other 510(k) Applications for this Company
Contact	THOMAS D NICKEL Other 510(k) Applications for this Contact
Regulation Number	880.5965   More FDA Info for this Regulation Number
Classification Product Code	LJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2000
Decision Date	10/27/2000
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