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FDA 510(k)

Rotarex Atherectomy System

K-Number: K242757 · 2025-01-30

ApplicantBard Peripheral Vascular, Inc.
Decision Date2025-01-30
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Rotarex Atherectomy System is a medical device manufactured by Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2025-01-30 under approval number K242757. 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 Rotarex Atherectomy System?

Rotarex Atherectomy System is a medical device that received FDA 510(k) clearance on 2025-01-30. It is manufactured by Bard Peripheral Vascular, Inc.. The 510(k) number is K242757.

When was Rotarex Atherectomy System approved by the FDA?

Rotarex Atherectomy System received FDA 510(k) clearance on 2025-01-30, under approval number K242757.

What company makes Rotarex Atherectomy System?

Rotarex Atherectomy System is manufactured by Bard Peripheral Vascular, Inc..

What is the FDA product code for Rotarex Atherectomy System?

The FDA product code for Rotarex Atherectomy System is MCW.

Related Clinical Trials

NCT04229563 Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease COMPLETED NCT07105930 Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach RECRUITING

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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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