FDA 510(k) Application Details - K180705

Device Classification Name	Catheter, Thrombus Retriever   More FDA Info for this Device
510(K) Number	K180705
Device Name	Catheter, Thrombus Retriever
Applicant	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Ryan Kenney Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	NRY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/19/2018
Decision Date	07/04/2018
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