FDA 510(k)

Arrow Stiffening Stylet

K 號：K220280 · 2022-08-30

申請人Arrow International, LLC (A subsidiary of Teleflex, Inc.)

決定日期2022-08-30

產品代碼DRB

諮詢委員會履歷

決定相當於

器材摘要

Arrow Stiffening Stylet is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, LLC (A subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2022-08-30 under 510(k) number K220280. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Arrow Stiffening Stylet?

Arrow Stiffening Stylet is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Arrow International, LLC (A subsidiary of Teleflex, Inc.). The 510(k) number is K220280.

When did Arrow Stiffening Stylet receive FDA 510(k) clearance?

Arrow Stiffening Stylet received FDA 510(k) clearance on 2022-08-30, under 510(k) number K220280.

Who is the listed applicant for Arrow Stiffening Stylet?

The FDA 510(k) record lists Arrow International, LLC (A subsidiary of Teleflex, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arrow Stiffening Stylet?

The FDA product code for Arrow Stiffening Stylet is DRB.

其他以 Arrow International, LLC (A subsidiary of Teleflex, 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。

K243599Arrow™ Endurance™ 延長停留周邊導管系統 (EDC-00818)K242281Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)K220363VPS Rhythm DLX 裝置，配備 TipTracker 技術

相關器械（代碼：DRB）

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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