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USCI Doppler Catheter System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K810414

by C. R. Bard, Inc.

Identifiers

510(k) Number
K810414 FDA 510(k)
FDA Product Code
JOP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2880 FDA 510(k)
Regulation Number
870.2880 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The USCI Doppler Catheter System is a Transducer, Ultrasonic device designed for cardiovascular applications. It incorporates Doppler ultrasound technology to measure and evaluate blood flow within catheters, aiding in diagnostic assessments of cardiac and vascular conditions.

This system is intended for use in clinical settings where real-time blood flow monitoring is required, such as during cardiac catheterization procedures. Supplied as a reusable device under regulatory classification JOP and 870.2880, it was granted FDA 510(k) clearance in 1981 under a Substantially Equivalent (SESE) determination. No third-party review was involved, and the device falls under Class II – Special Controls for medical devices.

Frequently asked questions

What clinical procedures is the USCI Doppler Catheter System primarily used for, and how does it assist in those procedures?

The USCI Doppler Catheter System is designed for use during cardiac catheterization procedures, where real-time monitoring of blood flow is critical. By incorporating Doppler ultrasound technology, it measures and evaluates blood flow within catheters, helping clinicians assess cardiac and vascular conditions. This aids in diagnosing issues like stenosis, valve function, or perfusion problems by providing immediate feedback on hemodynamics.

Is the USCI Doppler Catheter System intended for single-use or reusable applications, and what does this mean for maintenance?

The USCI Doppler Catheter System is supplied as a reusable device, as indicated by its regulatory classification (JOP). This means it is designed for repeated use in clinical settings after proper cleaning, disinfection, and maintenance procedures. Reusability requires adherence to manufacturer guidelines for sterilization and upkeep to ensure safety and performance across multiple procedures.

What regulatory pathway was followed for the FDA clearance of this device, and what does that imply about its oversight?

The USCI Doppler Catheter System received FDA 510(k) clearance in 1981 under a Substantially Equivalent (SESE) determination, meaning it was deemed comparable to a legally marketed device already on the market at the time. The clearance was granted without third-party review, and the device falls under Class II – Special Controls, indicating it is subject to additional regulatory scrutiny beyond general controls. This classification reflects its role in cardiovascular diagnostics, where precision and safety are critical.

Are there multiple models or sizes available for the USCI Doppler Catheter System, and how might this affect its application?

The provided data lists multiple registration numbers (e.g., 3010611950, 1216677, etc.), which often correspond to different models or variations of the device. While exact specifications like catheter sizes or transducer types aren’t detailed here, these variations likely cater to different procedural needs—such as pediatric vs. adult applications or specific catheter diameters. Clinicians should consult the manufacturer’s documentation to confirm compatibility with their intended use case.

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: USCI DOPPLER CATHETER SYSTEM (K810414) - FDA 510 (k), USCI DOPPLER CATHETER SYSTEM (K810414) — FDA 510(k) | Innolitics, Usci Doppler Catheter System 510 (k) K810414 - FDA.report, USCI DOPPLER CATHETER SYSTEM (K810414) - FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K810414 24 fields · synced Sep 19, 2026