FDA 510(k) Application Details - K990284

Device Classification Name	Catheter, Septostomy   More FDA Info for this Device
510(K) Number	K990284
Device Name	Catheter, Septostomy
Applicant	BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 5 MISSISSAUGA L4W-4T7 CA Other 510(k) Applications for this Company
Contact	KRIS SHAH 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	01/29/1999
Decision Date	02/01/2001
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