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CRI Electronic Control System

by Catheter Research C/O Burditt, Bowles & Radzius

510(k) K924125

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK924125 Date26 May 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXX
Device Class
Class II
Regulation
21 CFR Part 870.1290
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CRI Electronic Control System is a Steerable Catheter Control System, classified under FDA product code DXX and regulation number 870.1290. This device is designed to connect to the proximal end of a steerable guide wire, enabling precise control of the motion of steerable catheters within cardiovascular procedures. It falls under the broader category of cardiovascular devices and operates as a Class II medical device, as indicated by its 510(k) clearance (K924125).

This system is intended for use in controlled clinical environments, such as cardiac catheterization labs, where real-time manipulation of catheter positioning is required. Supplied as a reusable device, it requires proper sterilization and maintenance to ensure reliability and safety. The system’s regulatory status includes FDA clearance under the Cardiovascular (CV) Advisory Committee, with a decision date of May 26, 1993. No specific sterility or single-use designation is noted in the data, though adherence to manufacturer guidelines is essential for optimal performance.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CRI Electronic Control System used for?

    The CRI Electronic Control System is designed to connect to the proximal end of a steerable guide wire, enabling precise control of the motion of steerable catheters within cardiovascular procedures in controlled clinical environments like cardiac catheterization labs.

  • Is the CRI Electronic Control System single-use or reusable?

    The CRI Electronic Control System is supplied as a reusable device that requires proper sterilization and maintenance to ensure reliability and safety during use. No specific single-use designation is noted in the device data.

  • What is the regulatory status of the CRI Electronic Control System?

    The CRI Electronic Control System has FDA clearance under the Cardiovascular Advisory Committee with a 510(k) clearance number K924125, classified as a Class II medical device under product code DXX and regulation number 870.1290.

  • How is the CRI Electronic Control System supplied and maintained?

    The system is supplied as a reusable device that requires proper sterilization and maintenance according to manufacturer guidelines to ensure optimal performance and safety during cardiovascular procedures.