Heli-FX EndoAnchor System

Endovascular Suturing System

Medtronic Vascular, Inc.

The following data is part of a premarket notification filed by Medtronic Vascular, Inc. with the FDA for Heli-fx Endoanchor System.

Pre-market Notification Details

Device IDK182957
510k NumberK182957
Device Name:Heli-FX EndoAnchor System
ClassificationEndovascular Suturing System
Applicant Medtronic Vascular, Inc. 3850 Brickway Blvd Santa Rosa,  CA  95403
ContactJanelle Wong Keller
CorrespondentJanelle Wong Keller
Medtronic Vascular, Inc. 3850 Brickway Blvd Santa Rosa,  CA  95403
Product CodeOTD  
CFR Regulation Number870.3460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-24
Decision Date2018-11-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000645182 K182957 000
00763000645175 K182957 000
00763000645168 K182957 000
00763000645151 K182957 000
00763000645144 K182957 000
00763000645137 K182957 000
00763000645120 K182957 000
00763000645113 K182957 000

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