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FDA 510(k)

Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled

Número K: K200205 · 2020-05-13

RequerenteStryker Sustainability Solutions
Data da decisão2020-05-13
Código do produtoNLH
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2020-05-13 under 510(k) number K200205. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled?

Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is a medical device that received FDA 510(k) clearance on 2020-05-13. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K200205.

When did Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled receive FDA 510(k) clearance?

Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled received FDA 510(k) clearance on 2020-05-13, under 510(k) number K200205.

Who is the listed applicant for Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled?

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

What is the FDA product code for Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled?

The FDA product code for Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is NLH.

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