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FDA 510(k)

ROTAPRO Rotational Atherectomy System

K-Number: K220962 · 2022-09-06

ApplicantBoston Scientific Corporation
Decision Date2022-09-06
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ROTAPRO Rotational Atherectomy System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-09-06 under approval number K220962. 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 ROTAPRO Rotational Atherectomy System?

ROTAPRO Rotational Atherectomy System is a medical device that received FDA 510(k) clearance on 2022-09-06. It is manufactured by Boston Scientific Corporation. The 510(k) number is K220962.

When was ROTAPRO Rotational Atherectomy System approved by the FDA?

ROTAPRO Rotational Atherectomy System received FDA 510(k) clearance on 2022-09-06, under approval number K220962.

What company makes ROTAPRO Rotational Atherectomy System?

ROTAPRO Rotational Atherectomy System is manufactured by Boston Scientific Corporation.

What is the FDA product code for ROTAPRO Rotational Atherectomy System?

The FDA product code for ROTAPRO Rotational Atherectomy System is MCW.

Related Clinical Trials

NCT04229563 Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease COMPLETED NCT04674969 Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature RECRUITING NCT04200937 IT Matters: The Erectile Restoration Registry ENROLLING_BY_INVITATION NCT02686125 Vercise™ DBS Dystonia Prospective Study RECRUITING NCT04032470 Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET) RECRUITING NCT03735667 ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement ACTIVE_NOT_RECRUITING

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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. K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, 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.

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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