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FDA 510(k)

HawkOne Directional Atherectomy System

K-Number: K161361 · 2016-10-14

ApplicantMedtronic Vascular, Inc.
Decision Date2016-10-14
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HawkOne Directional Atherectomy 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 2016-10-14 under 510(k) number K161361. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HawkOne Directional Atherectomy System?

HawkOne Directional Atherectomy System is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Medtronic Vascular, Inc.. The 510(k) number is K161361.

When did HawkOne Directional Atherectomy System receive FDA 510(k) clearance?

HawkOne Directional Atherectomy System received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161361.

Who is the listed applicant for HawkOne Directional Atherectomy 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 HawkOne Directional Atherectomy System?

The FDA product code for HawkOne Directional Atherectomy System is MCW.

Related Clinical Trials

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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 HypertensionRECRUITING

Other records listing Medtronic Vascular, Inc. as applicant

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Related Devices (Code: MCW)

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.

K260244Auryon Atherectomy SystemEximo MedicalK250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectraneticsK242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.

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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