FDA 510(k)

超科爾旋轉乳腺組織標記器

K 號：K152510 · 2016-05-13

決定日期2016-05-13

產品代碼NEU

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

UltraCor Twirl Breast Tissue Marker is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K152510. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UltraCor Twirl Breast Tissue Marker?

UltraCor Twirl Breast Tissue Marker is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K152510.

When did UltraCor Twirl Breast Tissue Marker receive FDA 510(k) clearance?

UltraCor Twirl Breast Tissue Marker received FDA 510(k) clearance on 2016-05-13, under 510(k) number K152510.

Who is the listed applicant for UltraCor Twirl Breast Tissue Marker?

FDA 510(k) 記錄將 Bard Peripheral Vascular, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for UltraCor Twirl Breast Tissue Marker?

The FDA product code for UltraCor Twirl Breast Tissue Marker is NEU.

其他以 Bard Peripheral Vascular, 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。

K262571EnCor EnCompass™ 乳癌切片及組織移除系統 K260012超分數™ 焦點力量PTA氣球 K252681EnCor EnCompass™ 乳癌切片及組織移除系統 K250032Marquee™ 拋棄式核心切片器械及器械套組 K250219Dorado™ PTA 擴張球囊心导管 K243642UltraCor™ Twirl™ 乳組織標記器

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相關器械（代碼：NEU）

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。

K253761HydroMARK™ Plus 乳癌切片位置標記器（龍飛形狀）；HydroMARK™ Plus 乳癌切片位置標記器（蜂鳥形狀）Devicor Medical Products, Inc.K253888MOLLI 2 系統Stryker Endoscopy K252892SCOUT MD 外科導航系統Merit Medical Systems, Inc.K251989VizMark 預載組織標記設備（VM-0001）Breast-Med, Inc.K251748MammoSTAR 繭組切片位置識別器Carbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ 乳組織標記器Bard Peripheral Vascular, Inc.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。