FDA 510(k) Application Details - K021580

Device Classification Name	Port & Catheter, Implanted, Subcutaneous, Intravascular   More FDA Info for this Device
510(K) Number	K021580
Device Name	Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant	LEMAITRE VASCULAR, INC. 26 RAY AVE. BURLINGTON, MA 01803 US Other 510(k) Applications for this Company
Contact	JAMES ASHBY 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	05/14/2002
Decision Date	02/12/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review