FDA 510(k) Application Details - K031949

Device Classification Name	Catheter, Septostomy   More FDA Info for this Device
510(K) Number	K031949
Device Name	Catheter, Septostomy
Applicant	BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 33 MISSISSAUGA, ONTARIO L4W-4T7 CA Other 510(k) Applications for this Company
Contact	AMANDA HARTLEY Other 510(k) Applications for this Contact
Regulation Number	870.5175   More FDA Info for this Regulation Number
Classification Product Code	DXF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/24/2003
Decision Date	12/10/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review