FDA 510(k) Application Details - K182944

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K182944
Device Name	Device, Vascular, For Promoting Embolization
Applicant	KA Medical, LLC 2890 Centre Pointe Drive Roseville, MN 55113 US Other 510(k) Applications for this Company
Contact	John Oslund Other 510(k) Applications for this Contact
Regulation Number	870.3300   More FDA Info for this Regulation Number
Classification Product Code	KRD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2018
Decision Date	04/17/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review