FDA 510(k)

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

Número K: K190194 · 2019-05-31

RequerentePentax Medical, A Division of Pentax of America, Inc.

Data da decisão2019-05-31

Código do produtoGEH

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical, A Division of Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K190194. 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 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge?

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is Pentax Medical, A Division of Pentax of America, Inc.. The 510(k) number is K190194.

When did C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge receive FDA 510(k) clearance?

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge received FDA 510(k) clearance on 2019-05-31, under 510(k) number K190194.

Who is the listed applicant for C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge?

The FDA 510(k) record lists Pentax Medical, A Division of Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge?

The FDA product code for C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge is GEH.

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