FDA 510(k) Application Details - K242076

Device Classification Name	Catheter, Septostomy   More FDA Info for this Device
510(K) Number	K242076
Device Name	Catheter, Septostomy
Applicant	Baylis Medical Company 5825 Explorer Drive Mississauga L4W5P6 CA Other 510(k) Applications for this Company
Contact	Neethi Murali 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	07/16/2024
Decision Date	11/01/2024
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