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FDA 510(k)

FULL CARE Disposable PVC Nelaton Catheter

N.º K: K151745 · 2016-03-03

SolicitanteShaoxing Fuqing Health Products Co., Ltd.
Fecha de decisión2016-03-03
Código de productoEZD
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

FULL CARE Disposable PVC Nelaton Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Shaoxing Fuqing Health Products Co., Ltd.. It received FDA 510(k) clearance on 2016-03-03 under 510(k) number K151745. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FULL CARE Disposable PVC Nelaton Catheter?

FULL CARE Disposable PVC Nelaton Catheter is a medical device that received FDA 510(k) clearance on 2016-03-03. The listed applicant is Shaoxing Fuqing Health Products Co., Ltd.. The 510(k) number is K151745.

When did FULL CARE Disposable PVC Nelaton Catheter receive FDA 510(k) clearance?

FULL CARE Disposable PVC Nelaton Catheter received FDA 510(k) clearance on 2016-03-03, under 510(k) number K151745.

Who is the listed applicant for FULL CARE Disposable PVC Nelaton Catheter?

The FDA 510(k) record lists Shaoxing Fuqing Health Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FULL CARE Disposable PVC Nelaton Catheter?

The FDA product code for FULL CARE Disposable PVC Nelaton Catheter is EZD.

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Dispositivos relacionados (Código: EZD)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K261418Liquick X-treme, Liquick X-treme PlusTeleflex MedicalK260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated

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.

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