FDA 510(k)

Vortek Single Loop Ureteral Stent

N.º K: K201436 · 2021-02-25

Fecha de decisión2021-02-25

Código de productoFAD

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Vortek Single Loop Ureteral Stent is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K201436. 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 Vortek Single Loop Ureteral Stent?

Vortek Single Loop Ureteral Stent is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Coloplast Corp.. The 510(k) number is K201436.

When did Vortek Single Loop Ureteral Stent receive FDA 510(k) clearance?

Vortek Single Loop Ureteral Stent received FDA 510(k) clearance on 2021-02-25, under 510(k) number K201436.

Who is the listed applicant for Vortek Single Loop Ureteral Stent?

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

What is the FDA product code for Vortek Single Loop Ureteral Stent?

The FDA product code for Vortek Single Loop Ureteral Stent is FAD.

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Otros registros que enlistan a Coloplast Corp. como solicitante

K252140Heylo™ System K251116Luja Coudé K250270Luja Set K242049SureCath Set K241210Luja Coude K242173Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)

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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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