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ACROTHERM

by Aquarius Medical Corp.

510(k) K003368

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 NumberK003368 Date19 Jan 2001ClearedStatusActive

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  • Withdrawn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
DWJ
Device Class
Class II
Regulation
21 CFR Part 870.5900
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

ACROTHERM is a System, Thermal Regulating device classified as a Class II medical device by the FDA. It is intended for use in cardiovascular applications, as indicated by its classification and associated advisory committee review.

The device is supplied as a single-use item and is not reusable. It is not specified whether it is sterile or non-sterile, and no information is provided regarding MRI safety, storage conditions, or regulatory authorizations beyond its FDA 510(k) clearance.

Other devices from Aquarius Medical Corp.

Questions

AI-generated answers, 26 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 ACROTHERM device used for?

    ACROTHERM is a thermal regulating system intended for use in cardiovascular applications.

  • Is the ACROTHERM device reusable?

    No, the ACROTHERM device is supplied as a single-use item and is not reusable.

  • What regulatory authorization does the ACROTHERM have?

    The ACROTHERM device has FDA 510(k) clearance, which indicates it has been reviewed and determined to be substantially equivalent to a predicate device.