FDA 510(k)

cryoICE cryoXT cryoablation probe (cryoXT)

Número K: K250371 · 2025-04-10

Data da decisão2025-04-10

Código do produtoGXH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

cryoICE cryoXT cryoablation probe (cryoXT) is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K250371. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the cryoICE cryoXT cryoablation probe (cryoXT)?

cryoICE cryoXT cryoablation probe (cryoXT) is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is AtriCure, Inc.. The 510(k) number is K250371.

When did cryoICE cryoXT cryoablation probe (cryoXT) receive FDA 510(k) clearance?

cryoICE cryoXT cryoablation probe (cryoXT) received FDA 510(k) clearance on 2025-04-10, under 510(k) number K250371.

Who is the listed applicant for cryoICE cryoXT cryoablation probe (cryoXT)?

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

What is the FDA product code for cryoICE cryoXT cryoablation probe (cryoXT)?

The FDA product code for cryoICE cryoXT cryoablation probe (cryoXT) is GXH.

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Outros registros que listam AtriCure, Inc. como candidato(a)

K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)K243860AtriClip PRO-Mini LAA Exclusion System (PROM)K243157AtriCure cryoICE BOX (ACM)K234151Isolator Synergy EnCapture Ablation System (EMH)K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)K233959EPi-Ease Epicardial Access Device (EAS)

Ver todos os 32 dispositivos →

Dispositivos Relacionados (Código: GXH)

K243677iovera° SystemPacira Biosciences, Inc.K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)AtriCure, Inc.K220656iovera SystemPacira Biosciences, Inc.K211334Iovera SystemPacira Pharmaceuticals, Inc.K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)AtriCure, Inc.

Fonte oficial

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