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FDA 510(k)

SureLead Cable System

Número K: K181089 · 2020-01-17

RequerenteAuthentic Medical
Data da decisão2020-01-17
Código do produtoDSA
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

SureLead Cable System is the device name listed in this FDA 510(k) record. The listed applicant is Authentic Medical. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K181089. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SureLead Cable System?

SureLead Cable System is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Authentic Medical. The 510(k) number is K181089.

When did SureLead Cable System receive FDA 510(k) clearance?

SureLead Cable System received FDA 510(k) clearance on 2020-01-17, under 510(k) number K181089.

Who is the listed applicant for SureLead Cable System?

The FDA 510(k) record lists Authentic Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SureLead Cable System?

The FDA product code for SureLead Cable System is DSA.

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