FDA 510(k)

Zenysis Short-Term Dialysis Catheter

Número K: K163458 · 2017-04-04

Data da decisão2017-04-04

Código do produtoMPB

Comité consultivoGU

DecisãoUnknown

Resumo do dispositivo

Zenysis Short-Term Dialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2017-04-04 under 510(k) number K163458. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the Zenysis Short-Term Dialysis Catheter?

Zenysis Short-Term Dialysis Catheter is a medical device that received FDA 510(k) clearance on 2017-04-04. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K163458.

When did Zenysis Short-Term Dialysis Catheter receive FDA 510(k) clearance?

Zenysis Short-Term Dialysis Catheter received FDA 510(k) clearance on 2017-04-04, under 510(k) number K163458.

Who is the listed applicant for Zenysis Short-Term Dialysis Catheter?

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

What is the FDA product code for Zenysis Short-Term Dialysis Catheter?

The FDA product code for Zenysis Short-Term Dialysis Catheter is MPB.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam C.R. Bard, Inc. como candidato(a)

K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)K251864Rubber Utility Catheter K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,

Ver todos os 67 dispositivos →

Dispositivos Relacionados (Código: MPB)

K25083614F Duo-Flow® Cateter de Doble Lumeno Lado a LadoMedical Components, Inc.K200426Cáteter Hemodialis de Dúbito Luminoso AgudoHealth Line International Corporation K192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp)K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLC K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated K153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.