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CLC2000 Catheter Patency Device

by ICU Medical, Inc.

510(k) K021692

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK021692 Date4 Dec 2003ClearedStatusActive

Official records

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  • Withdrawn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
FPA
Device class
Class II
Regulation
21 CFR Part 880.5440
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 25 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 CLC2000 Catheter Patency Device is an accessory to a vascular access device designed to assist in maintaining catheter patency. It functions by reducing thrombotic occlusion within the internal catheter lumen and minimizing fibrin formation. Additionally, the device is designed to be needle-free, which aids in the reduction of needlestick injuries.

This device is a Class 2 General Hospital device cleared through the FDA 510(k) pathway under K021692. It is manufactured by ICU Medical, Inc. and is intended for use as a component in clinical settings.

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