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Cool Line Catheter Kit, Models Cl-2085B, Cl-2295A; Icy Catheter Kit, Model Ic-3585A; Fortius Catheter Kit, Mod. Fr-5093B

by Alsius Corp.

510(k) K051912

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)SESU Traditional NumberK051912 Date11 Oct 2005ClearedStatusActive

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  • Withdrawn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
NCX
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.5900
Advisory Committee
Cardiovascular
FDA Decision
SESU

Overview

AI-generated summary, 19 Sep 2026

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

This device is a System, Hypothermia, Intravenous, Cooling catheter kit designed for therapeutic hypothermia applications in cardiovascular procedures. It facilitates controlled cooling of intravenous fluids to achieve targeted temperature reduction, aiding in the management of conditions requiring systemic hypothermia, such as post-cardiac arrest care or neuroprotection during critical interventions.

The kits are supplied as sterile, single-use disposable systems and are intended for use in clinical settings where precise temperature control is required. Each model includes specific catheter and tubing configurations for intravenous administration, with regulatory compliance under FDA 510(k) clearance (K051912). Storage and handling follow standard sterile medical device protocols, and compatibility with MRI environments is not specified.

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Questions

AI-generated answers, 19 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 Cool Line Catheter Kit intended for?

    The device is designed for therapeutic hypothermia applications in cardiovascular procedures, facilitating controlled cooling of intravenous fluids to achieve targeted temperature reduction for conditions such as post-cardiac arrest care or neuroprotection during critical interventions.

  • How is the Cool Line Catheter Kit supplied and is it reusable?

    The kits are supplied as sterile, single-use disposable systems, meaning each unit is intended for one-time use only and must be discarded after a single procedure to maintain sterility and safety.

  • What models are included in the Cool Line Catheter Kit system?

    The system includes the Cool Line Catheter Kit models CL-2085B and CL-2295A, the Icy Catheter Kit model IC-3585A, and the Fortius Catheter Kit model FR-5093B, each with specific catheter and tubing configurations for intravenous administration.

  • What regulatory pathway was used for the Cool Line Catheter Kit?

    The device received regulatory clearance through the FDA 510(k) pathway, as indicated by the authorization type FDA_510K and the specific k-number K051912.

  • Are there any special storage or handling requirements for the Cool Line Catheter Kit?

    Storage and handling follow standard sterile medical device protocols, and the device is supplied in a sterile condition requiring appropriate storage to maintain integrity until use.