FDA 510(k)

CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit

K-Nummer: K200306 · 2020-03-06

AntragstellerAbbott (Formerly Thoratec Corporation)

Entscheidungsdatum2020-03-06

ProduktcodeDWA

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit is the device name listed in this FDA 510(k) record. The listed applicant is Abbott (Formerly Thoratec Corporation). It received FDA 510(k) clearance on 2020-03-06 under 510(k) number K200306. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit?

CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is Abbott (Formerly Thoratec Corporation). The 510(k) number is K200306.

When did CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit receive FDA 510(k) clearance?

CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit received FDA 510(k) clearance on 2020-03-06, under 510(k) number K200306.

Who is the listed applicant for CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit?

The FDA 510(k) record lists Abbott (Formerly Thoratec Corporation) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit?

The FDA product code for CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit is DWA.

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Verwandte Geräte (Code: DWA)

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