FDA 510(k) Application Details - K023914

Device Classification Name	Catheter, Intravascular Occluding, Temporary   More FDA Info for this Device
510(K) Number	K023914
Device Name	Catheter, Intravascular Occluding, Temporary
Applicant	COAXIA INC 10900 73RD AVE. N. MAPLE GROVE, MN 55369 US Other 510(k) Applications for this Company
Contact	GREGORY W SACHS 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	11/25/2002
Decision Date	02/21/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review