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FDA 510(k)

Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette

K-Number: K171427 · 2017-06-13

ApplicantMedtronic Vascular, Inc.
Decision Date2017-06-13
Product CodeOTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette is a medical device manufactured by Medtronic Vascular, Inc.. It received FDA 510(k) clearance on 2017-06-13 under approval number K171427. 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 Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette?

Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette is a medical device that received FDA 510(k) clearance on 2017-06-13. It is manufactured by Medtronic Vascular, Inc.. The 510(k) number is K171427.

When was Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette approved by the FDA?

Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette received FDA 510(k) clearance on 2017-06-13, under approval number K171427.

What company makes Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette?

Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette is manufactured by Medtronic Vascular, Inc..

What is the FDA product code for Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette?

The FDA product code for Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette is OTD.

Other Devices by Medtronic Vascular, Inc.

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Related Devices (Code: OTD)

K182957Heli-FX EndoAnchor SystemMedtronic 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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