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React 68 Catheter

by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

510(k) K180715

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK180715 Date4 Jul 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

The React 68 Catheter is a single-lumen, variable-stiffness, percutaneous catheter designed for navigating peripheral and neurovascular anatomy. It is used for the introduction of interventional devices into the peripheral and neuro vasculature.

The React 68 Catheter is supplied as a Class 2 Cardiovascular device with product code DQY. It has been cleared through the Traditional 510(k) pathway and has FDA 510(k) clearance, indicated by the k number K180715. The device features a coil and braid design along with end-to-end nitinol construction.

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Questions

AI-generated answers, 22 Sep 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 React 68 Catheter used for?

    The React 68 Catheter is designed for navigating peripheral and neurovascular anatomy and is used to introduce interventional devices into the peripheral and neuro vasculature, enabling access for procedures such as embolization or stent placement in complex vascular pathways.

  • How is the React 68 Catheter supplied and is it reusable?

    The React 68 Catheter is supplied as a single-use, sterile device intended for one-time patient use only; it is not designed for cleaning, resterilization, or reuse due to its variable-stiffness construction and risk of material degradation or contamination after initial use.

  • What regulatory pathway was used for the React 68 Catheter and what is its product code?

    The React 68 Catheter received FDA 510(k) clearance through the Traditional pathway under product code DQY, with k-number K180715, indicating it was found substantially equivalent to a legally marketed predicate device.