FDA 510(k) Application Details - K152335

Device Classification Name	Catheter, Embolectomy   More FDA Info for this Device
510(K) Number	K152335
Device Name	Catheter, Embolectomy
Applicant	Medtronic, Inc. 37A Cherry Hill Drive Danvers, MA 01923 US Other 510(k) Applications for this Company
Contact	Colleen Mullins Other 510(k) Applications for this Contact
Regulation Number	870.5150   More FDA Info for this Regulation Number
Classification Product Code	DXE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2015
Decision Date	09/18/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review