FDA 510(k) Application Details - K251044

Device Classification Name	More FDA Info for this Device
510(K) Number	K251044
Device Name	93 NeuFlex Catheter
Applicant	Piraeus Medical 7351 Kirkwood Ln N Maple Grove, MN 55369 US Other 510(k) Applications for this Company
Contact	Jared Hutar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2025
Decision Date	05/23/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review