FDA 510(k)

PowerWire 電波頻率導絲套件

K 號：K232562 · 2024-02-28

決定日期2024-02-28

產品代碼PDU

諮詢委員會履歷

決定Unknown

器材摘要

PowerWire Radiofrequency Guidewire Kit is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-02-28 under 510(k) number K232562. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

常見問題

What is the PowerWire Radiofrequency Guidewire Kit?

PowerWire Radiofrequency Guidewire Kit is a medical device that received FDA 510(k) clearance on 2024-02-28. The listed applicant is Baylis Medical Technologies, Inc.. The 510(k) number is K232562.

When did PowerWire Radiofrequency Guidewire Kit receive FDA 510(k) clearance?

PowerWire Radiofrequency Guidewire Kit received FDA 510(k) clearance on 2024-02-28, under 510(k) number K232562.

Who is the listed applicant for PowerWire Radiofrequency Guidewire Kit?

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

What is the FDA product code for PowerWire Radiofrequency Guidewire Kit?

The FDA product code for PowerWire Radiofrequency Guidewire Kit is PDU.

其他以 Baylis Medical Technologies, 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：PDU）

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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