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FDA 510(k)

TurboHawk Plus Directional Atherectomy System

K-Number: K212027 · 2021-08-24

ApplicantMedtronic, Inc.
Decision Date2021-08-24
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TurboHawk Plus Directional Atherectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2021-08-24 under 510(k) number K212027. 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 TurboHawk Plus Directional Atherectomy System?

TurboHawk Plus Directional Atherectomy System is a medical device that received FDA 510(k) clearance on 2021-08-24. The listed applicant is Medtronic, Inc.. The 510(k) number is K212027.

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

TurboHawk Plus Directional Atherectomy System received FDA 510(k) clearance on 2021-08-24, under 510(k) number K212027.

Who is the listed applicant for TurboHawk Plus Directional Atherectomy System?

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

What is the FDA product code for TurboHawk Plus Directional Atherectomy System?

The FDA product code for TurboHawk Plus Directional Atherectomy System is MCW.

Related Clinical Trials

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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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