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FDA 510(k)

Coldplay 冷凍氣球；焦點消融系統，全消融系統；掃描消融系統

K 號：K152329 · 2016-04-13

申請人C2 Therapeutics, Inc.
決定日期2016-04-13
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; 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.

常見問題

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.

相關臨床試驗

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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。

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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。

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官方來源

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