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FDA 510(k)

Biotronik Stylets

K 號：K191469 · 2019-08-01

申請人Biotronik, Inc.
決定日期2019-08-01
產品代碼DRB
諮詢委員會CV
決定Substantially Equivalent

器材摘要

Biotronik Stylets is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2019-08-01 under 510(k) number K191469. 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 Biotronik Stylets?

Biotronik Stylets is a medical device that received FDA 510(k) clearance on 2019-08-01. The listed applicant is Biotronik, Inc.. The 510(k) number is K191469.

When did Biotronik Stylets receive FDA 510(k) clearance?

Biotronik Stylets received FDA 510(k) clearance on 2019-08-01, under 510(k) number K191469.

Who is the listed applicant for Biotronik Stylets?

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

What is the FDA product code for Biotronik Stylets?

The FDA product code for Biotronik Stylets is DRB.

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其他以 Biotronik, 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：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。

K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)K182660GaltTWSGalt Medical Corp.K170298Liberator Beacon Tip Locking StyletCook Incorporated

官方來源

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