FDA 510(k)

Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System

Número K: K152329 · 2016-04-13

Data da decisão2016-04-13

Código do produtoGEH

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is C2 Therapeutics, Inc.. It received FDA 510(k) clearance on 2016-04-13 under 510(k) number K152329. 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 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System?

Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System is a medical device that received FDA 510(k) clearance on 2016-04-13. The listed applicant is C2 Therapeutics, Inc.. The 510(k) number is K152329.

When did Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System receive FDA 510(k) clearance?

Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System received FDA 510(k) clearance on 2016-04-13, under 510(k) number K152329.

Who is the listed applicant for Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System?

The FDA 510(k) record lists C2 Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System?

The FDA product code for Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System is GEH.

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Outros registros que listam C2 Therapeutics, Inc. como candidato(a)

K163684C2 CryoBalloon Ablation System K161202C2 Cryoballoon Ablation System K160994C2 CryoBalloon Focal Pear Catheter K153541Coldplay CryoBalloon® Ablation System

Dispositivos Relacionados (Código: GEH)

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH K252198Removendorrugas a Crisoterapia Avançado (Removendorrugas Avançado)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.

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