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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 the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2025-01-30 under 510(k) 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. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K242757.

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

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

Who is the listed applicant for Rotarex Atherectomy System?

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

What is the FDA product code for Rotarex Atherectomy System?

The FDA product code for Rotarex 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 CatheterSpectraneticsK242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)Cardio Flow 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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