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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular, Inc.. It received FDA 510(k) clearance on 2017-06-13 under 510(k) 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. The listed applicant is Medtronic Vascular, Inc.. The 510(k) number is K171427.

When did Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette receive FDA 510(k) clearance?

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

Who is the listed applicant for Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette?

The FDA 510(k) record lists Medtronic Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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Other records listing Medtronic Vascular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P160043Coronary drug-eluting stentPMA P110023STENT, SUPERFICIAL FEMORAL ARTERYPMA P060001Stent, carotidPMA P190008Drug-coated peripheral transluminal angioplasty catheterPMA P100021SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTPMA P200026Stent, iliac vein

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Related Devices (Code: OTD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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