FDA 510(k)

ViaCath, AcQRate Dx Steerable Catheter

Número K: K212593 · 2021-10-15

Data da decisão2021-10-15

Código do produtoDRF

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ViaCath, AcQRate Dx Steerable Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Biotronick, Inc.. It received FDA 510(k) clearance on 2021-10-15 under 510(k) number K212593. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ViaCath, AcQRate Dx Steerable Catheter?

ViaCath, AcQRate Dx Steerable Catheter is a medical device that received FDA 510(k) clearance on 2021-10-15. The listed applicant is Biotronick, Inc.. The 510(k) number is K212593.

When did ViaCath, AcQRate Dx Steerable Catheter receive FDA 510(k) clearance?

ViaCath, AcQRate Dx Steerable Catheter received FDA 510(k) clearance on 2021-10-15, under 510(k) number K212593.

Who is the listed applicant for ViaCath, AcQRate Dx Steerable Catheter?

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

What is the FDA product code for ViaCath, AcQRate Dx Steerable Catheter?

The FDA product code for ViaCath, AcQRate Dx Steerable Catheter is DRF.

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