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Thermogard Thermal Regulation System

by Alsius Corp.

510(k) K063829

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 Special NumberK063829 Date22 Jan 2007ClearedStatusActive

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  • Withdrawn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
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.

The Thermogard Thermal Regulation System is a System, Hypothermia, Intravenous, Cooling device designed for intravascular thermal regulation. It is classified as a Class II medical device under FDA regulation 870.5900 and is intended for use in controlled thermal modulation, including normothermia maintenance and mild hypothermia induction or reversal during surgical and intensive care procedures.

This system is supplied as a reusable device and is intended for use in cardiovascular and neurosurgical settings. It operates via an intravascular catheter (Icy™ or Fortius™ models) and is regulated under FDA 510(k) clearance (K063829). Sterility and single-use requirements are not specified, but proper cleaning and maintenance protocols must be followed as per manufacturer guidelines to ensure safe, repeated use in clinical environments.

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