FDA 510(k)

EleVation 乳癌切片系統

K 號：K211933 · 2021-07-15

決定日期2021-07-15

產品代碼KNW

諮詢委員會GU

決定相當於

器材摘要

EleVation Breast 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 2021-07-15 under 510(k) number K211933. 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 EleVation Breast Biopsy System?

EleVation Breast Biopsy System is a medical device that received FDA 510(k) clearance on 2021-07-15. The listed applicant is Bard Peripheral Vascular. The 510(k) number is K211933.

When did EleVation Breast Biopsy System receive FDA 510(k) clearance?

EleVation Breast Biopsy System received FDA 510(k) clearance on 2021-07-15, under 510(k) number K211933.

Who is the listed applicant for EleVation Breast 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 EleVation Breast Biopsy System?

The FDA product code for EleVation Breast 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。

K213896BD Trek 髓骨活體組織採集系統

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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