FDA 510(k)

Coldplay 冷凍氣球® 消融系統

K 號：K153541 · 2016-01-07

決定日期2016-01-07

產品代碼GEH

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Coldplay CryoBalloon® 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 2016-01-07 under 510(k) number K153541. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Coldplay CryoBalloon® Ablation System?

Coldplay CryoBalloon® Ablation System is a medical device that received FDA 510(k) clearance on 2016-01-07. The listed applicant is C2 Therapeutics, Inc.. The 510(k) number is K153541.

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

Coldplay CryoBalloon® Ablation System received FDA 510(k) clearance on 2016-01-07, under 510(k) number K153541.

Who is the listed applicant for Coldplay CryoBalloon® 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® Ablation System?

The FDA product code for Coldplay CryoBalloon® Ablation System is GEH.

其他以 C2 Therapeutics, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K163684C2冷氣球消融系統 K161202C2冷氣球消融系統 K160994C2冷氣球焦點梨形心导管 K152329Coldplay 冷凍氣球；焦點消融系統，全消融系統；掃描消融系統

相關器械（代碼：GEH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262420Maverix 冷凍切片儀 Pro (MCB Pro) (MCBP-1000)；Maverix 冷凍針筒 (CC-1000)Serpex Medical K261068Maverix冷凍切片探針（MCB1000）；Maverix冷凍針筒（CC1000）Serpex Medical K261806ERBECRYO 2 冷凍外科儀器及附件Erbe Elektromedizin GmbH K253230ERBECRYO 2 冷凍外科儀器及附件：ERBECRYO 2 冷凍外科儀器；Erbe 柔性冷凍針Erbe Elektromedizin GmbH K252198Advanced 冷冻皮肤疣去除器（Advanced 皮肤疣去除器）Medical Brands Laboratories B.V.K260377XSense冷凍消融系統搭配冷凍探針IceCure Medical , Ltd.

官方來源

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