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FDA 510(k)

TSP Crosser Transseptal Access System

Número K: K181088 · 2018-09-28

RequerenteTransseptal Solutions , Ltd.
Data da decisão2018-09-28
Código do produtoDYB
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

TSP Crosser Transseptal Access System is the device name listed in this FDA 510(k) record. The listed applicant is Transseptal Solutions , Ltd.. It received FDA 510(k) clearance on 2018-09-28 under 510(k) number K181088. 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 TSP Crosser Transseptal Access System?

TSP Crosser Transseptal Access System is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Transseptal Solutions , Ltd.. The 510(k) number is K181088.

When did TSP Crosser Transseptal Access System receive FDA 510(k) clearance?

TSP Crosser Transseptal Access System received FDA 510(k) clearance on 2018-09-28, under 510(k) number K181088.

Who is the listed applicant for TSP Crosser Transseptal Access System?

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

What is the FDA product code for TSP Crosser Transseptal Access System?

The FDA product code for TSP Crosser Transseptal Access System is DYB.

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Fonte oficial

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