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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endovascular Suturing System
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
Applicant Contact Burt Goodson
Correspondent
Medtronic Vascular, Inc.
3850 Brickway Blvd
Santa Rosa,  CA  95403
Correspondent Contact Burt Goodson
Regulation Number870.3460
Classification Product Code
OTD  
Date Received05/15/2017
Decision Date 06/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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