FDA 510(k)

Dib UltraNav Transseptal Catheter System

Número K: K213492 · 2022-03-24

Data da decisão2022-03-24

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dib UltraNav Transseptal Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Dib Ultranav Medical, LLC. It received FDA 510(k) clearance on 2022-03-24 under 510(k) number K213492. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dib UltraNav Transseptal Catheter System?

Dib UltraNav Transseptal Catheter System is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Dib Ultranav Medical, LLC. The 510(k) number is K213492.

When did Dib UltraNav Transseptal Catheter System receive FDA 510(k) clearance?

Dib UltraNav Transseptal Catheter System received FDA 510(k) clearance on 2022-03-24, under 510(k) number K213492.

Who is the listed applicant for Dib UltraNav Transseptal Catheter System?

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

What is the FDA product code for Dib UltraNav Transseptal Catheter System?

The FDA product code for Dib UltraNav Transseptal Catheter System is DYB.

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