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FDA 510(k)

CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)

Número K: K251928 · 2026-02-13

RequerenteMedinice S.A.
Data da decisão2026-02-13
Código do produtoGEH
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) is the device name listed in this FDA 510(k) record. The listed applicant is Medinice S.A.. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K251928. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)?

CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Medinice S.A.. The 510(k) number is K251928.

When did CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) receive FDA 510(k) clearance?

CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) received FDA 510(k) clearance on 2026-02-13, under 510(k) number K251928.

Who is the listed applicant for CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)?

The FDA 510(k) record lists Medinice S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)?

The FDA product code for CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) is GEH.

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Dispositivos Relacionados (Código: GEH)

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