FDA 510(k) Application Details - K234074

Device Classification Name	More FDA Info for this Device
510(K) Number	K234074
Device Name	Next Generation Access Catheter
Applicant	Balt USA, LLC 29 Parker Irvine, CA 92604 US Other 510(k) Applications for this Company
Contact	Catherine Chiou 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	12/22/2023
Decision Date	07/02/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review