AtriCure cryoICE BOX (ACM) — 510(k) de la FDA K243157

Resumen del dispositivo

AtriCure cryoICE BOX (ACM) is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K243157. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AtriCure cryoICE BOX (ACM)?

AtriCure cryoICE BOX (ACM) is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is AtriCure, Inc.. The 510(k) number is K243157.

When did AtriCure cryoICE BOX (ACM) receive FDA 510(k) clearance?

AtriCure cryoICE BOX (ACM) received FDA 510(k) clearance on 2024-10-29, under 510(k) number K243157.

Who is the listed applicant for AtriCure cryoICE BOX (ACM)?

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 AtriCure cryoICE BOX (ACM)?

The FDA product code for AtriCure cryoICE BOX (ACM) is GXH.

Ensayos clínicos relacionados

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Otros registros que enlistan a AtriCure, Inc. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)K250371cryoICE cryoXT cryoablation probe (cryoXT)K243860AtriClip PRO-Mini LAA Exclusion System (PROM)K234151Isolator Synergy EnCapture Ablation System (EMH)K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)K233959EPi-Ease Epicardial Access Device (EAS)

Ver todos los 32 dispositivos →

Dispositivos relacionados (Código: GXH)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.K243677iovera° SystemPacira Biosciences, 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.

Fuente oficial

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