FDA 510(k)

重製 VersaCross 操控導管；重製 SureFlex 操控導引導管

K 號：K232037 · 2024-04-04

決定日期2024-04-04

產品代碼PNE

諮詢委員會履歷

決定相當於

器材摘要

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K232037. The device is classified under product code PNE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath?

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Innovative Health, LLC. The 510(k) number is K232037.

When did Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath receive FDA 510(k) clearance?

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath received FDA 510(k) clearance on 2024-04-04, under 510(k) number K232037.

Who is the listed applicant for Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath?

The FDA 510(k) record lists Innovative Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath?

The FDA product code for Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath is PNE.

其他以 Innovative Health, LLC 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：PNE）

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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