FDA 510(k) Application Details - K150709

Device Classification Name	Catheter, Septostomy   More FDA Info for this Device
510(K) Number	K150709
Device Name	Catheter, Septostomy
Applicant	BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST MISSISSAUGA L4W 5S4 CA Other 510(k) Applications for this Company
Contact	Meghal Khakhar 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	03/19/2015
Decision Date	06/17/2015
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