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TransXchange Support Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K033540

by Medtronic Vascular

Identifiers

510(k) Number
K033540 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 TransXchange Support Catheter is a guidewire exchange and infusion catheter classified under product code DQY. It is designed to provide structural support during guidewire exchanges in peripheral vascular procedures, facilitating the safe transition of guidewires while maintaining vessel access. The device also serves as a conduit for the administration of saline solutions or diagnostic contrast agents, aiding in diagnostic imaging and procedural support. Its primary function aligns with vascular interventions requiring catheter-based access and manipulation.

This catheter is intended for single-use in clinical settings such as catheterization labs or interventional radiology suites. It is supplied sterile and requires no additional sterilization before use. The device is regulated under FDA 510(k) clearance (K033540) and falls under the Cardiovascular advisory committee classification. No additional regulatory markings or MRI safety considerations are specified in the available data.

Frequently asked questions

What is the primary purpose of the TransXchange Support Catheter in vascular procedures?

The TransXchange Support Catheter is designed to provide structural support during guidewire exchanges in peripheral vascular procedures. This helps ensure a smooth transition of guidewires while keeping the vessel access stable. Additionally, it acts as a conduit for infusing saline solutions or diagnostic contrast agents, which aids in diagnostic imaging and procedural support.

Is the TransXchange Support Catheter intended for reuse, or is it meant to be used only once?

The TransXchange Support Catheter is explicitly intended for single-use in clinical settings like catheterization labs or interventional radiology suites. It is supplied sterile and does not require additional sterilization before use, reinforcing its one-time-use design.

What types of solutions can be administered through the TransXchange Support Catheter, and why?

The catheter is designed to administer saline solutions or diagnostic contrast agents through its lumen. This functionality supports diagnostic imaging during procedures and helps maintain vessel access by flushing or diluting substances as needed.

How is the TransXchange Support Catheter regulated, and what does that mean for its use?

The TransXchange Support Catheter is regulated under FDA 510(k) clearance (K033540) and classified under product code DQY, with a decision of *Substantially Equivalent* to a predicate device. This means it has undergone FDA review to confirm it is as safe and effective as a previously cleared device, ensuring compliance with U.S. regulatory standards for vascular catheters.

Are there any special handling or storage requirements for the TransXchange Support Catheter?

The catheter is supplied sterile and does not require additional sterilization before use, as it is designed for single-use. While specific storage conditions (e.g., temperature, humidity) aren’t detailed in the data, standard sterile medical device storage practices—such as protecting from contamination and extreme temperatures—should be followed to maintain integrity until use.

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: TRANSXCHANGE SUPPORT CATHETER (K033540) — FDA 510(k) | Innolitics, Transxchange Support Catheter - Medtronic Vascular | FDA Reference, TRANSXCHANGE SUPPORT CATHETER 510 (k) K033540 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K033540 24 fields · synced Oct 6, 2026