FDA 510(k)

再處理 ViewFlex Xtra ICE 球囊電極

K 號：K182238 · 2019-05-08

決定日期2019-05-08

產品代碼OWQ

諮詢委員會履歷

決定相當於

器材摘要

Reprocessed ViewFlex Xtra ICE Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2019-05-08 under 510(k) number K182238. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Reprocessed ViewFlex Xtra ICE Catheter?

Reprocessed ViewFlex Xtra ICE Catheter is a medical device that received FDA 510(k) clearance on 2019-05-08. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K182238.

When did Reprocessed ViewFlex Xtra ICE Catheter receive FDA 510(k) clearance?

Reprocessed ViewFlex Xtra ICE Catheter received FDA 510(k) clearance on 2019-05-08, under 510(k) number K182238.

Who is the listed applicant for Reprocessed ViewFlex Xtra ICE Catheter?

The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed ViewFlex Xtra ICE Catheter?

The FDA product code for Reprocessed ViewFlex Xtra ICE Catheter is OWQ.

其他以 Stryker Sustainability Solutions 為申請人之記錄

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相關器械（代碼：OWQ）

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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