FDA 510(k)

BioGuard Válvulas de Aire/Agua y Succión

N.º K: K203630 · 2021-01-08

Fecha de decisión2021-01-08

Código de productoODC

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

BioGuard Air/Water and Suction Valves is the device name listed in this FDA 510(k) record. The listed applicant is Steris Corporations. It received FDA 510(k) clearance on 2021-01-08 under 510(k) number K203630. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BioGuard Air/Water and Suction Valves?

BioGuard Air/Water and Suction Valves is a medical device that received FDA 510(k) clearance on 2021-01-08. The listed applicant is Steris Corporations. The 510(k) number is K203630.

When did BioGuard Air/Water and Suction Valves receive FDA 510(k) clearance?

BioGuard Air/Water and Suction Valves received FDA 510(k) clearance on 2021-01-08, under 510(k) number K203630.

Who is the listed applicant for BioGuard Air/Water and Suction Valves?

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

What is the FDA product code for BioGuard Air/Water and Suction Valves?

The FDA product code for BioGuard Air/Water and Suction Valves is ODC.

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Otros registros que enlistan a Steris Corporations como solicitante

K190104SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System K183295Celeridad HP Indicador Químico (CI)K183300VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack K182931VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag K180342SYSTEM 1E Liquid Chemical Sterilant Processing System K172748VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack

Ver todos los 7 dispositivos →

Dispositivos relacionados (Código: ODC)

K252933DYNE PORTDyne Medical Group, Inc.K250145Adaptador de Puerta de BiopsiaEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston Scientific K250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems Corporation K250732Juego de Válvula de Endoscopia DesechableYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.