FDA 510(k) Application Details - K043023

Device Classification Name	Catheter, Intravascular Occluding, Temporary   More FDA Info for this Device
510(K) Number	K043023
Device Name	Catheter, Intravascular Occluding, Temporary
Applicant	LEMAITRE VASCULAR, INC. 63 2ND AVENUE BURLINGTON, MA 01803 US Other 510(k) Applications for this Company
Contact	SABA MODJARRAD Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	MJN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2004
Decision Date	12/03/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review