FDA 510(k) Application Details - K171427

Device Classification Name	More FDA Info for this Device
510(K) Number	K171427
Device Name	Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette
Applicant	Medtronic Vascular, Inc. 3850 Brickway Blvd Santa Rosa, CA 95403 US Other 510(k) Applications for this Company
Contact	Burt Goodson 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	05/15/2017
Decision Date	06/13/2017
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