FDA 510(k)

DORA一次性A.V.動脈針套組

K 號：K163025 · 2017-07-20

申請人Bain Medical Equipment (Guangzhou) Co., Ltd.

決定日期2017-07-20

產品代碼FIE

諮詢委員會GU

決定相當於

器材摘要

DORA Disposable A.V. Fistula Needle Sets is the device name listed in this FDA 510(k) record. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2017-07-20 under 510(k) number K163025. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DORA Disposable A.V. Fistula Needle Sets?

DORA Disposable A.V. Fistula Needle Sets is a medical device that received FDA 510(k) clearance on 2017-07-20. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K163025.

When did DORA Disposable A.V. Fistula Needle Sets receive FDA 510(k) clearance?

DORA Disposable A.V. Fistula Needle Sets received FDA 510(k) clearance on 2017-07-20, under 510(k) number K163025.

Who is the listed applicant for DORA Disposable A.V. Fistula Needle Sets?

The FDA 510(k) record lists Bain Medical Equipment (Guangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DORA Disposable A.V. Fistula Needle Sets?

The FDA product code for DORA Disposable A.V. Fistula Needle Sets is FIE.

其他以 Bain Medical Equipment (Guangzhou) Co., Ltd. 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。

K252423NovaLine 血液透析管路組 (BL 124)K240164NovaLine SP-C35 超聲波傳感器保護器（956007）K213015DORA一次性A.V.動脈針套組 K201866NovaLine 血液透析管路套件 K203524外科口罩 K161582DORA 血液透析管路套件

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相關器械（代碼：FIE）

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。

K253469Ritus™ 安全造口針管配防逆流閥 15G x 30mm (1530VSMM)；Ritus™ 安全造口針管配防逆流閥 15G x 38mm (1538VSMM)；Ritus™ 安全造口針管配防逆流閥 16G x 30mm (1630VSMM)；Ritus™ 安全造口針管配防逆流閥 16G x 38mm (1638VSMM)；Ritus™ 安全造口針管配防逆流閥 17G x 30mm (1730VSMM)；Ritus™ 安全造口針管配防逆流閥 17G x 38mm (1738VSMM)Mozarc Medical Us, LLC K251877JMS CAVEO A.V. 腹股溝針組JMS North America Corporation K213015DORA一次性A.V.動脈針套組Bain Medical Equipment (Guangzhou) Co., Ltd.K171505Dimesol 一次性動靜脈造口針組（非安全系列）及Dimesol 一次性動靜脈造口針組（安全系列）Dimesol, Inc.

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