FDA 510(k)

FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm

Número K: K161967 · 2017-01-27

Data da decisão2017-01-27

Código do produtoKRA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm is the device name listed in this FDA 510(k) record. The listed applicant is Callisyn Biomedical, Inc.. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K161967. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm?

FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Callisyn Biomedical, Inc.. The 510(k) number is K161967.

When did FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm receive FDA 510(k) clearance?

FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm received FDA 510(k) clearance on 2017-01-27, under 510(k) number K161967.

Who is the listed applicant for FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm?

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

What is the FDA product code for FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm?

The FDA product code for FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm is KRA.

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Fonte oficial

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