FDA 510(k) Application Details - K251376

Device Classification Name	More FDA Info for this Device
510(K) Number	K251376
Device Name	LimFlow ARC
Applicant	LimFlow Inc. 6001 Oak Canyon Suite 100 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Haley Ritchie Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2025
Decision Date	05/31/2025
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