FDA 510(k)

BD Trek 髓骨活體組織採集系統

K 號：K213896 · 2022-03-30

決定日期2022-03-30

產品代碼KNW

諮詢委員會GU

決定相當於

器材摘要

BD Trek Powered Bone Biopsy System is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular. It received FDA 510(k) clearance on 2022-03-30 under 510(k) number K213896. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BD Trek Powered Bone Biopsy System?

BD Trek Powered Bone Biopsy System is a medical device that received FDA 510(k) clearance on 2022-03-30. The listed applicant is Bard Peripheral Vascular. The 510(k) number is K213896.

When did BD Trek Powered Bone Biopsy System receive FDA 510(k) clearance?

BD Trek Powered Bone Biopsy System received FDA 510(k) clearance on 2022-03-30, under 510(k) number K213896.

Who is the listed applicant for BD Trek Powered Bone Biopsy System?

The FDA 510(k) record lists Bard Peripheral Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Trek Powered Bone Biopsy System?

The FDA product code for BD Trek Powered Bone Biopsy System is KNW.

其他以 Bard Peripheral Vascular 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。

K211933EleVation 乳癌切片系統

相關器械（代碼：KNW）

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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