FDA 510(k)

Trio-CT® Triple Lumen Catheter w/ Curved Extensions

Número K: K232945 · 2023-11-16

RequerenteMedical Components, Inc. (dba MedComp)

Data da decisão2023-11-16

Código do produtoNIE

Comité consultivoGU

DecisãoUnknown

Resumo do dispositivo

Trio-CT® Triple Lumen Catheter w/ Curved Extensions is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc. (dba MedComp). It received FDA 510(k) clearance on 2023-11-16 under 510(k) number K232945. The device is classified under product code NIE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the Trio-CT® Triple Lumen Catheter w/ Curved Extensions?

Trio-CT® Triple Lumen Catheter w/ Curved Extensions is a medical device that received FDA 510(k) clearance on 2023-11-16. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K232945.

When did Trio-CT® Triple Lumen Catheter w/ Curved Extensions receive FDA 510(k) clearance?

Trio-CT® Triple Lumen Catheter w/ Curved Extensions received FDA 510(k) clearance on 2023-11-16, under 510(k) number K232945.

Who is the listed applicant for Trio-CT® Triple Lumen Catheter w/ Curved Extensions?

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

What is the FDA product code for Trio-CT® Triple Lumen Catheter w/ Curved Extensions?

The FDA product code for Trio-CT® Triple Lumen Catheter w/ Curved Extensions is NIE.

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Outros registros que listam Medical Components, Inc. (dba MedComp) como candidato(a)

K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes K192807Duo-Flow Side x Side Double Lumen Catheter K183219Trio-CT Triple Lumen Catheter K18117512F Tri-Flow Triple Lumen Catheter K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes K180567C3 Wave System

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Dispositivos Relacionados (Código: NIE)

K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)K18117512F Tri-Flow Triple Lumen CatheterMedical Components, Inc. (dba MedComp)

Fonte oficial

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