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Intravascular Catheter W/Doppler Transducer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K860121

by NuMED, Inc.

Identifiers

510(k) Number
K860121 FDA 510(k)
FDA Product Code
DPT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2120 FDA 510(k)
Regulation Number
870.2120 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an intravascular catheter with an integrated Doppler transducer, classified under the nomenclature for blood-flow probes. It is designed for use within blood vessels to measure and assess blood flow dynamics, enabling real-time monitoring of hemodynamic parameters. The Doppler transducer component facilitates non-invasive velocity and flow rate measurements, aiding in diagnostic and interventional cardiovascular procedures.

The catheter is supplied as a single-use medical device and is intended for use in controlled clinical settings, such as cardiac catheterization labs. It is regulated under FDA 510(k) clearance (K860121) and falls under the Device Product Code (DPT) for blood-flow probes. No specific MRI safety or sterility details are provided in the data, but standard sterile packaging is implied for intravascular use. The device is listed under the Cardiovascular advisory committee and adheres to FDA regulation 870.2120.

Frequently asked questions

What is the intravascular catheter with Doppler transducer used for?

This device is designed to measure and assess blood flow dynamics within blood vessels in real-time. The integrated Doppler transducer enables non-invasive velocity and flow rate measurements, supporting diagnostic and interventional procedures in cardiovascular care, such as those performed in cardiac catheterization labs.

Is the NuMED Doppler catheter intended for single-use or reuse?

The device is explicitly supplied as a single-use medical device. This ensures patient safety and sterility, as single-use catheters are not intended for reuse between patients, reducing the risk of contamination or infection.

What regulatory approval does the NuMED Doppler catheter hold?

The device holds FDA 510(k) clearance under the classification for blood-flow probes, with the clearance number K860121. It adheres to FDA regulation 870.2120 and was reviewed by the Cardiovascular Advisory Committee, confirming its substantial equivalence to prior-generation devices.

Where is this catheter typically used, and what settings are appropriate?

This catheter is intended for use in controlled clinical settings, such as cardiac catheterization labs. The design supports real-time hemodynamic monitoring during procedures where precise blood flow assessment is critical, such as during diagnostic evaluations or interventional treatments.

Are there specific storage instructions for the NuMED Doppler catheter?

While the provided data does not specify storage instructions, standard sterile packaging is implied for intravascular devices. It is recommended to store the catheter in a clean, dry environment, away from direct sunlight or extreme temperatures, to maintain its integrity and sterility 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: INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER (K860121) — FDA 510(k ..., Intravascular Catheter W/Doppler Transducer - Beudamed, PDF K860121 - Intravascular Catheter W/Doppler Transducer, NuMED, Inc. — 49 FDA 510 (k)s · DeviceClearance, NuMED, Inc. - 47 FDA 510 (k) Cardiovascular Devices (2022)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
NuMED, Inc.

Sources (1)

  • FDA 510(k) K860121 24 fields · synced Oct 1, 2026