FDA 510(k) Application Details - K231393

Device Classification Name	More FDA Info for this Device
510(K) Number	K231393
Device Name	Radical the Dude 7F Guide Catheter
Applicant	Maduro Medical, Inc. 1731 Dell Avenue Campbell, CA 95008 US Other 510(k) Applications for this Company
Contact	Janice Kemp 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	05/12/2023
Decision Date	11/30/2023
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