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FDA 510(k)

Rotarex Atherectomy System

K-Number: K211738 · 2021-09-14

ApplicantC.R. Bard, Inc.
Decision Date2021-09-14
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Rotarex Atherectomy System is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2021-09-14 under approval number K211738. 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 2021-09-14. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K211738.

When was Rotarex Atherectomy System approved by the FDA?

Rotarex Atherectomy System received FDA 510(k) clearance on 2021-09-14, under approval number K211738.

What company makes Rotarex Atherectomy System?

Rotarex Atherectomy System is manufactured by C.R. Bard, Inc..

What is the FDA product code for Rotarex Atherectomy System?

The FDA product code for Rotarex Atherectomy System is MCW.

Related Clinical Trials

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Related Devices (Code: MCW)

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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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