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FDA 510(k)

Cure Catheter Closed System; Cure Dextra Closed System

N.º K: K230400 · 2023-11-08

SolicitanteConvatec, Inc.
Fecha de decisión2023-11-08
Código de productoEZD
Comité asesorGU
DecisiónUnknown

Resumen del dispositivo

Cure Catheter Closed System; Cure Dextra Closed System is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, Inc.. It received FDA 510(k) clearance on 2023-11-08 under 510(k) number K230400. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Preguntas frecuentes

What is the Cure Catheter Closed System; Cure Dextra Closed System?

Cure Catheter Closed System; Cure Dextra Closed System is a medical device that received FDA 510(k) clearance on 2023-11-08. The listed applicant is Convatec, Inc.. The 510(k) number is K230400.

When did Cure Catheter Closed System; Cure Dextra Closed System receive FDA 510(k) clearance?

Cure Catheter Closed System; Cure Dextra Closed System received FDA 510(k) clearance on 2023-11-08, under 510(k) number K230400.

Who is the listed applicant for Cure Catheter Closed System; Cure Dextra Closed System?

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

What is the FDA product code for Cure Catheter Closed System; Cure Dextra Closed System?

The FDA product code for Cure Catheter Closed System; Cure Dextra Closed System is EZD.

Ensayos clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Convatec, Inc. como solicitante

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.

K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus

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

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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.

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