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FDA 510(k)

stay•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 inch

N.º K: K173593 · 2018-05-21

SolicitanteFresenius Medical Care Renal Therapies Group, LLC
Fecha de decisión2018-05-21
Código de productoKDJ
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

stay•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 inch 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 2018-05-21 under 510(k) number K173593. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the stay•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 inch?

stay•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 inch is a medical device that received FDA 510(k) clearance on 2018-05-21. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K173593.

When did stay•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 inch receive FDA 510(k) clearance?

stay•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 inch received FDA 510(k) clearance on 2018-05-21, under 510(k) number K173593.

Who is the listed applicant for stay•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 inch?

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 stay•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 inch?

The FDA product code for stay•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 inch is KDJ.

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Dispositivos relacionados (Código: KDJ)

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.

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 HealthcareK173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetFresenius Medical Care Renal Therapies Group, LLCK173363Cycler Drain Bag SetFresenius Medical Care Renal Therapies Group, LLC

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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