FDA 510(k)

Kurin 高壓 PIV 體內血液採集套件

K 號：K181895 · 2019-01-18

決定日期2019-01-18

產品代碼JKA

諮詢委員會CH

決定相當於

器材摘要

Kurin PIV Blood Collection Set with High Pressure is the device name listed in this FDA 510(k) record. The listed applicant is Kurin, Inc.. It received FDA 510(k) clearance on 2019-01-18 under 510(k) number K181895. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Kurin PIV Blood Collection Set with High Pressure?

Kurin PIV Blood Collection Set with High Pressure is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is Kurin, Inc.. The 510(k) number is K181895.

When did Kurin PIV Blood Collection Set with High Pressure receive FDA 510(k) clearance?

Kurin PIV Blood Collection Set with High Pressure received FDA 510(k) clearance on 2019-01-18, under 510(k) number K181895.

Who is the listed applicant for Kurin PIV Blood Collection Set with High Pressure?

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

What is the FDA product code for Kurin PIV Blood Collection Set with High Pressure?

The FDA product code for Kurin PIV Blood Collection Set with High Pressure is JKA.

其他以 Kurin, 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。

K220677Kurin血液培養收集套件，配備Kurin鎖定技術 K191832Kurin血液培養收集套組搭配Kurin鎖定技術，按鈕針（產品型號M-21221、M-21223、D-21221、D-21223、T-21221、T-21223）

相關器械（代碼：JKA）

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。

K262215Profoject™ 安全滑動血液收集套組CMT Health PTE., Ltd.K252899女性培養設備；男性培養設備；傳送設備；進入設備Zhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ 和 BD A-Line™ 动脈血液採集針筒Becton, Dickinson and Company K252378BD® MiniDraw™ 微量血採集系統配BD® MiniDraw™ SST™ 微量血採集管Becton, Dickinson and Company K252506BD Vacutainer® 安全鎖™ 採血套組; BD Vacutainer® 安全鎖™ 採血套組配預裝持桿器Becton, Dickinson and Company K252040BD Vacutainer® 血漿分離管 (PST™), BD Vacutainer® 钠鹽肝素採血管Becton, Dickinson and Company

官方來源

在 FDA 資料庫中查看 →

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。