FDA 510(k) Application Details - K231056

Device Classification Name	More FDA Info for this Device
510(K) Number	K231056
Device Name	Esperance Distal Access Catheter
Applicant	Wallaby Medical 22901 Mill Creek Drive Laguna Hills, CA 92653 US Other 510(k) Applications for this Company
Contact	Nathaniel Knock 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	04/13/2023
Decision Date	03/08/2024
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