FDA 510(k) Application Details - K240900

Device Classification Name	Catheter, Septostomy   More FDA Info for this Device
510(K) Number	K240900
Device Name	Catheter, Septostomy
Applicant	Atraverse Medical 2611 S Coast Hwy 101 #204 Cardiff by the Sea, CA 92007 US Other 510(k) Applications for this Company
Contact	Charles Yang 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	04/01/2024
Decision Date	05/01/2024
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	Y
Expedited Review