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FDA 510(k)

Heli-FX EndoAnchor System

K-Number: K182957 · 2018-11-21

ApplicantMedtronic Vascular, Inc.
Decision Date2018-11-21
Product CodeOTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Heli-FX EndoAnchor System is a medical device manufactured by Medtronic Vascular, Inc.. It received FDA 510(k) clearance on 2018-11-21 under approval number K182957. The device is classified under product code OTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Heli-FX EndoAnchor System?

Heli-FX EndoAnchor System is a medical device that received FDA 510(k) clearance on 2018-11-21. It is manufactured by Medtronic Vascular, Inc.. The 510(k) number is K182957.

When was Heli-FX EndoAnchor System approved by the FDA?

Heli-FX EndoAnchor System received FDA 510(k) clearance on 2018-11-21, under approval number K182957.

What company makes Heli-FX EndoAnchor System?

Heli-FX EndoAnchor System is manufactured by Medtronic Vascular, Inc..

What is the FDA product code for Heli-FX EndoAnchor System?

The FDA product code for Heli-FX EndoAnchor System is OTD.

Related Clinical Trials

NCT04503395 ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES RECRUITING NCT01534819 ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry) COMPLETED

Other Devices by Medtronic Vascular, Inc.

K161361HawkOne Directional Atherectomy System K171866Sentrant Introducer Sheath with Hydrophilic Coating K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette PMA P110023STENT, SUPERFICIAL FEMORAL ARTERY PMA P140018Agent, occluding, vascular, permanent

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Related Devices (Code: OTD)

K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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