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FDA 510(k)

Anivia SG1000 Pump Console

K-Number: K221491 · 2023-02-03

ApplicantApmtd, Inc.
Decision Date2023-02-03
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Anivia SG1000 Pump Console is the device name listed in this FDA 510(k) record. The listed applicant is Apmtd, Inc.. It received FDA 510(k) clearance on 2023-02-03 under 510(k) number K221491. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anivia SG1000 Pump Console?

Anivia SG1000 Pump Console is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is Apmtd, Inc.. The 510(k) number is K221491.

When did Anivia SG1000 Pump Console receive FDA 510(k) clearance?

Anivia SG1000 Pump Console received FDA 510(k) clearance on 2023-02-03, under 510(k) number K221491.

Who is the listed applicant for Anivia SG1000 Pump Console?

The FDA 510(k) record lists Apmtd, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anivia SG1000 Pump Console?

The FDA product code for Anivia SG1000 Pump Console is DWA.

Other records listing Apmtd, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230698Anivia SG1000 Pump Console

Related Devices (Code: DWA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232788INSPIRA ART100Inspira Technologies Oxy B.H.N. , Ltd.K230698Anivia SG1000 Pump ConsoleApmtd, Inc.K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureSpectrum Medical , Ltd.K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula KitAbbott (Formerly Thoratec Corporation)K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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