FDA 510(k) Application Details - K242051

Device Classification Name	More FDA Info for this Device
510(K) Number	K242051
Device Name	VersaD Delivery Catheter
Applicant	Unity Medical, Inc. 6987 Washington Ave South Edina, MN 55439 US Other 510(k) Applications for this Company
Contact	Matthew Ogle 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	07/12/2024
Decision Date	01/17/2025
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	Y
Expedited Review