FDA 510(k) Application Details - K182957

Device Classification Name	More FDA Info for this Device
510(K) Number	K182957
Device Name	Heli-FX EndoAnchor System
Applicant	Medtronic Vascular, Inc. 3850 Brickway Blvd Santa Rosa, CA 95403 US Other 510(k) Applications for this Company
Contact	Janelle Wong Keller Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/24/2018
Decision Date	11/21/2018
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