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Xtractor device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K211679

by Xcardia Innovation , Ltd.

Identifiers

510(k) Number
K211679 FDA 510(k)
FDA Product Code
DRE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1310 FDA 510(k)
Regulation Number
870.1310 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Xtractor device is a cardiovascular dilator designed for percutaneous catheterization. It is used to assist in vessel dilation during catheter-based procedures, facilitating access and navigation within the vascular system.

The device is supplied as a single-use, sterile product intended for clinical settings. It is regulated under FDA Class 2 with product code DRE and was cleared through the Traditional 510(k) pathway. Storage conditions and specific sizes are not detailed in the available data.

Frequently asked questions

What is the Xtractor device used for?

The Xtractor device is a cardiovascular dilator used during percutaneous catheterization procedures. It assists in dilating blood vessels to facilitate access and navigation within the vascular system, aiding clinicians in performing catheter-based interventions.

How is the Xtractor device supplied?

The Xtractor device is supplied as a single-use, sterile product intended for clinical settings. It is designed for one-time use to ensure patient safety and maintain sterility, and is not intended for reprocessing or reuse.

Is the Xtractor device reusable?

No, the Xtractor device is strictly single-use. It is supplied sterile and must be discarded after a single procedure. Reuse or reprocessing is not supported due to the risk of contamination, device degradation, and compromised performance.

What regulatory pathway was used for the Xtractor device?

The Xtractor device was cleared through the FDA Traditional 510(k) pathway under product code DRE (Dilator, Vessel, For Percutaneous Catheterization). It is classified as a Class II medical device and was determined to be substantially equivalent to an existing legally marketed device.

What storage conditions are required for the Xtractor device?

Specific storage conditions for the Xtractor device are not detailed in the available regulatory data. However, as a sterile, single-use device, it should be stored in a cool, dry environment away from direct sunlight and extreme temperatures until ready for use, in accordance with standard medical device handling practices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Xcardia Announces First-In-Human Use of its New Xtractor Device for ..., Xcardia Announces First-In-Human Use of its New Xtractor Device for ..., K211679 FDA 510(k) - Xtractor device | Xcardia Innovation , Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Xcardia Innovation , Ltd.

Sources (1)

  • FDA 510(k) K211679 24 fields · synced Sep 22, 2026