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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular, Inc.. It received FDA 510(k) clearance on 2018-11-21 under 510(k) 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. The listed applicant is Medtronic Vascular, Inc.. The 510(k) number is K182957.

When did Heli-FX EndoAnchor System receive FDA 510(k) clearance?

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

Who is the listed applicant for Heli-FX EndoAnchor System?

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 EndoAnchor System?

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

Related Clinical Trials

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.

NCT02439775SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation SystemCOMPLETEDNCT05198674SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTNACTIVE_NOT_RECRUITINGNCT06907147SPYRAL GEMINI Pilot StudyRECRUITINGNCT07115953Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled HypertensionRECRUITINGNCT07754318Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System China Study(ATHENA)NOT_YET_RECRUITING

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.

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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