FDA 510(k)

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes

Número K: K202176 · 2020-09-03

RequerenteMedical Components, Inc. (dba MedComp)

Data da decisão2020-09-03

Código do produtoMSD

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Fonte oficial

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