Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set

Número K: K173651 · 2018-02-14

RequerenteFresenius Medical Care Renal Therapies Group, LLC
Data da decisão2018-02-14
Código do produtoKDJ
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2018-02-14 under 510(k) number K173651. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set?

Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set is a medical device that received FDA 510(k) clearance on 2018-02-14. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K173651.

When did Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set receive FDA 510(k) clearance?

Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set received FDA 510(k) clearance on 2018-02-14, under 510(k) number K173651.

Who is the listed applicant for Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set?

The FDA 510(k) record lists Fresenius Medical Care Renal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set?

The FDA product code for Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set is KDJ.

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_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

Outros registros que listam Fresenius Medical Care Renal Therapies Group, LLC como candidato(a)

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.

K261267Careflux H60;Careflux H70;Careflux V500K252377NxStage System One with NxViewK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)K253518FX CorAL 40; FX CorAL 50K250634BCM2-Body Composition Monitor

Ver todos os 48 dispositivos →

Dispositivos Relacionados (Código: KDJ)

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.

K250404stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inchFresenius Medical Care Renal Therapies Group, LLCK231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483Baxter HealthcareK21401615L Cycler Drainage BagBaxter Healthcare CorporationK192705MiniCap Extended Life PD Transfer SetsBaxter HealthcareK173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inchFresenius Medical Care Renal Therapies Group, LLCK173363Cycler Drain Bag SetFresenius Medical Care Renal Therapies Group, LLC

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.

↑