FDA 510(k)

Vascette HP (hemostatic pad)

Número K: K220566 · 2022-07-29

Data da decisão2022-07-29

Código do produtoQSY

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vascette HP (hemostatic pad) is the device name listed in this FDA 510(k) record. The listed applicant is Koag, LLC. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K220566. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vascette HP (hemostatic pad)?

Vascette HP (hemostatic pad) is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Koag, LLC. The 510(k) number is K220566.

When did Vascette HP (hemostatic pad) receive FDA 510(k) clearance?

Vascette HP (hemostatic pad) received FDA 510(k) clearance on 2022-07-29, under 510(k) number K220566.

Who is the listed applicant for Vascette HP (hemostatic pad)?

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

What is the FDA product code for Vascette HP (hemostatic pad)?

The FDA product code for Vascette HP (hemostatic pad) is QSY.

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