FDA 510(k)

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes

N.º K: K202176 · 2020-09-03

SolicitanteMedical Components, Inc. (dba MedComp)

Fecha de decisión2020-09-03

Código de productoMSD

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes 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 2020-09-03 under 510(k) number K202176. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes?

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K202176.

When did Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes receive FDA 510(k) clearance?

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes received FDA 510(k) clearance on 2020-09-03, under 510(k) number K202176.

Who is the listed applicant for Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes?

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 Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes?

The FDA product code for Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes is MSD.

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Otros registros que enlistan a Medical Components, Inc. (dba MedComp) como solicitante

K232945Trio-CT® Triple Lumen Catheter w/ Curved Extensions 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: MSD)

K241581Hemodialysis CatheterHaolang Medical USA Corporation K210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.

Fuente oficial

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