FDA 510(k)

Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)

Número K: K253918 · 2026-06-02

Data da decisão2026-06-02

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) is the device name listed in this FDA 510(k) record. The listed applicant is F Care Systems USA, LLC. It received FDA 510(k) clearance on 2026-06-02 under 510(k) number K253918. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)?

Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is F Care Systems USA, LLC. The 510(k) number is K253918.

When did Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) receive FDA 510(k) clearance?

Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) received FDA 510(k) clearance on 2026-06-02, under 510(k) number K253918.

Who is the listed applicant for Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)?

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

What is the FDA product code for Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)?

The FDA product code for Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) is GEI.

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Outros registros que listam F Care Systems USA, LLC como candidato(a)

K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)K220725HPR45i K210077MED RF 4000

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Fonte oficial

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