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Guidion

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210110

by IMDS Operations B.V.

Identifiers

510(k) Number
K210110 FDA 510(k)
FDA Product Code
DQY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Guidion Rapid Exchange Guide Extension is a Rapid Exchange Guide Extension (product code DQY), a type of intravascular guidewire extension designed to facilitate coronary angiography and percutaneous coronary intervention (PCI). It provides structural support and enhances navigability through complex coronary anatomy, enabling precise catheter placement and lesion crossing in coronary arteries.

This device is supplied as a single-use, non-sterile product intended for use in cardiac catheterization laboratories. It is available in two sizes: 6F and 7F, as indicated by the model designation. The Guidion has been cleared under the FDA 510(k) pathway (K210110) as a Class II Cardiovascular device, with a Traditional 510(k) review process. Compliance with regulatory standards ensures its suitability for use in interventional cardiology procedures.

Frequently asked questions

What specific coronary procedures is the Guidion Rapid Exchange Guide Extension designed to assist with, and how does it improve the process?

The Guidion is designed to assist with coronary angiography and percutaneous coronary intervention (PCI), helping to provide structural support and improve navigability through complex coronary anatomy. Its rapid exchange design allows for precise catheter placement and easier lesion crossing in coronary arteries, reducing procedural challenges during these interventions.

Is the Guidion Rapid Exchange Guide Extension intended for reuse, or is it meant to be used only once per patient?

The Guidion is explicitly supplied as a single-use device, meaning it is intended for one-time use per patient and should not be reused. This aligns with standard practices for intravascular devices to ensure patient safety and sterility.

What sizes are available for the Guidion, and how would a clinician determine which size to use?

The Guidion is available in two sizes: 6F and 7F, as indicated by the model designation. The choice of size depends on the patient’s anatomy and the specific procedural requirements, such as the diameter of the guiding catheter or the complexity of the coronary arteries being treated.

How should the Guidion be stored, and is it sterile upon receipt?

The Guidion is supplied as a non-sterile product, meaning it requires terminal sterilization (e.g., ethylene oxide or gamma irradiation) by the healthcare facility before use. Proper storage should follow the manufacturer’s instructions to maintain its integrity until sterilization.

What regulatory pathway was followed for the Guidion’s clearance, and which advisory committee was involved?

The Guidion was cleared under the FDA’s 510(k) pathway, specifically through a Traditional 510(k) review process, and was deemed substantially equivalent to a predicate device. The Cardiovascular (CV) advisory committee was involved in the review process as part of the submission.

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: FlowGuide Rapid Exchange Guide Extension - IMDS, K210110 - Guidion | FDA 510 (k) | Imds Operations B.V., IMDS Operations B.V. Company Profile | Roden, Drenthe | Competitors ..., Imds Operations B.V. · DeviceClearance, Imds Operations B.V. - FDA Devices | MedTracker

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
IMDS Operations B.V.

Sources (1)

  • FDA 510(k) K210110 24 fields · synced Sep 18, 2026