FDA 510(k)

DORA Disposable A.V. Fistula Needle Sets

N.º K: K213015 · 2022-04-08

SolicitanteBain Medical Equipment (Guangzhou) Co., Ltd.

Fecha de decisión2022-04-08

Código de productoFIE

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

DORA Disposable A.V. Fistula Needle Sets is the device name listed in this FDA 510(k) record. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K213015. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the DORA Disposable A.V. Fistula Needle Sets?

DORA Disposable A.V. Fistula Needle Sets is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K213015.

When did DORA Disposable A.V. Fistula Needle Sets receive FDA 510(k) clearance?

DORA Disposable A.V. Fistula Needle Sets received FDA 510(k) clearance on 2022-04-08, under 510(k) number K213015.

Who is the listed applicant for DORA Disposable A.V. Fistula Needle Sets?

The FDA 510(k) record lists Bain Medical Equipment (Guangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DORA Disposable A.V. Fistula Needle Sets?

The FDA product code for DORA Disposable A.V. Fistula Needle Sets is FIE.

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Otros registros que enlistan a Bain Medical Equipment (Guangzhou) Co., Ltd. como solicitante

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Dispositivos relacionados (Código: FIE)

K253469Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)Mozarc Medical Us, LLC K251877JMS CAVEO A.V. Fistula Needle SetJMS North America Corporation K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)Dimesol, Inc.K163025DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.

Fuente oficial

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