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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 a medical device manufactured by Medtronic Vascular, Inc.. It received FDA 510(k) clearance on 2016-10-14 under approval 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. It is manufactured by Medtronic Vascular, Inc.. The 510(k) number is K161361.

When was HawkOne Directional Atherectomy System approved by the FDA?

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

What company makes HawkOne Directional Atherectomy System?

HawkOne Directional Atherectomy System is manufactured by Medtronic Vascular, Inc..

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

NCT04229563 Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease COMPLETED NCT07572318 Pilot Study on the Feasibility of High-energy Collimation With Optimized Geometry on a VERITON™ CZT Camera NOT_YET_RECRUITING NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT07105930 Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach RECRUITING NCT05971693 A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator COMPLETED

Other Devices by Medtronic Vascular, Inc.

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Related Devices (Code: MCW)

K163264Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox SledAvinger, Inc. K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc. K160827Pantheris CatheterAvinger, Inc. K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersSpectranetics, Inc. K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox SledAvinger, 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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