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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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-09-06 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K220962.

When did ROTAPRO Rotational Atherectomy System receive FDA 510(k) clearance?

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

Who is the listed applicant for ROTAPRO Rotational Atherectomy System?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

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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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