FDA 510(k)

C2 冷凍バルーン消融システム（C2 冷凍バルーン消融システム）

K番号: K240457 · 2024-07-24

決定日2024-07-24

製品コードGEH

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K240457. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)?

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Pentax of America, Inc.. The 510(k) number is K240457.

When did C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) receive FDA 510(k) clearance?

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) received FDA 510(k) clearance on 2024-07-24, under 510(k) number K240457.

Who is the listed applicant for C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)?

The FDA 510(k) record lists 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 Ablation System (C2 CryoBalloon Ablation System)?

The FDA product code for C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) is GEH.

申請者としてPentax of America, Inc.を記載するその他の記録

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