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Aspire Mechanical Aspirator G

by Control Medical Technology

510(k) K200629

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 · Special NumberK200629 Date29 May 2020ClearedStatusActive

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  • Withdrawn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
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Aspire Mechanical Aspirator G is a mechanical aspiration device designed for the removal of fluid, blood clots, or debris from vascular or cardiac access sites. Classified under 21 CFR 870.5150 as an embolic aspiration catheter, it is intended for use in interventional procedures to clear occlusions or obstructions in blood vessels, aiding in the restoration of blood flow. Its mechanical design enables controlled suction to safely extract thrombi or other obstructions during percutaneous interventions.

This device is supplied as a single-use, sterile, disposable instrument and is intended for use in MRI-safe environments (non-ferromagnetic components). It is regulated under FDA 510(k) clearance (K200629) as a Class II General Hospital device with product code FMF, cleared via the Special 510(k) pathway. Storage and handling must adhere to sterile medical device protocols, and its use is restricted to trained clinical personnel in procedural settings such as catheterization labs or cardiac catheterization units.

Other devices from Control Medical Technology

Questions

AI-generated answers, 1 Oct 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 Aspire Mechanical Aspirator G used for?

    The Aspire Mechanical Aspirator G is designed specifically for removing fluid, blood clots, or debris from vascular or cardiac access sites during interventional procedures. It helps restore blood flow by clearing occlusions or obstructions in blood vessels, making it ideal for percutaneous interventions like thrombus extraction in catheterization labs or cardiac catheterization units.

  • Is the Aspire Mechanical Aspirator G single-use or reusable?

    The Aspire Mechanical Aspirator G is supplied as a single-use, disposable device. This design ensures sterility and reduces the risk of cross-contamination between patients, adhering to standard sterile medical device protocols for procedural settings.

  • Can this device be used in MRI environments?

    Yes, the Aspire Mechanical Aspirator G is designed for use in MRI-safe environments. It contains non-ferromagnetic components, which is critical for compatibility with magnetic resonance imaging systems during or after procedures.

  • What regulatory clearance does the Aspire Mechanical Aspirator G hold?

    The Aspire Mechanical Aspirator G holds FDA 510(k) clearance (K200629) under the Special 510(k) pathway. It is classified as a Class II General Hospital device with product code FMF, indicating it meets regulatory standards for embolic aspiration catheters as defined under 21 CFR 870.5150.

  • How should the Aspire Mechanical Aspirator G be stored?

    The Aspire Mechanical Aspirator G must be stored according to sterile medical device protocols to maintain its integrity and sterility. Proper storage conditions include keeping it in its original packaging, away from direct sunlight or extreme temperatures, and ensuring it remains uncontaminated until use by trained clinical personnel.