FDA 510(k) Application Details - K202318

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K202318
Device Name	Catheter, Continuous Flush
Applicant	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Elizabeth Campion Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2020
Decision Date	09/14/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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