FDA 510(k) Application Details - K250542

Device Classification Name	System, Balloon, Intra-Aortic And Control   More FDA Info for this Device
510(K) Number	K250542
Device Name	System, Balloon, Intra-Aortic And Control
Applicant	Arrow International LLC (Subsidiary of Teleflex Incorporated) 3015 Carrington Mill Boulevard Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Apurva Gokhale Other 510(k) Applications for this Contact
Regulation Number	870.3535   More FDA Info for this Regulation Number
Classification Product Code	DSP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2025
Decision Date	03/26/2025
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