FDA 510(k) Application Details - K243193

Device Classification Name	Catheter, Septostomy   More FDA Info for this Device
510(K) Number	K243193
Device Name	Catheter, Septostomy
Applicant	Circa Scientific, Inc. 14 Inverness Dr E, Suite H-136 Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Jennifer Willner 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	09/30/2024
Decision Date	11/26/2024
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