FDA 510(k)

Dornier Ureteral Stent

N.º K: K190312 · 2019-11-15

SolicitanteDornier Medtech America, Inc.

Fecha de decisión2019-11-15

Código de productoFAD

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dornier Ureteral Stent is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K190312. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Dornier Ureteral Stent?

Dornier Ureteral Stent is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K190312.

When did Dornier Ureteral Stent receive FDA 510(k) clearance?

Dornier Ureteral Stent received FDA 510(k) clearance on 2019-11-15, under 510(k) number K190312.

Who is the listed applicant for Dornier Ureteral Stent?

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

What is the FDA product code for Dornier Ureteral Stent?

The FDA product code for Dornier Ureteral Stent is FAD.

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Dispositivos relacionados (Código: FAD)

K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd.K251469Endura™ Ureteral Stent and Stent SetCathegenix (Xiamen) Co., Ltd.K243039Ureteral Stents (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.K243830Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd.K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent SetBoston Scientific Corporation K232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company

Fuente oficial

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