FDA 510(k)

KIDS 靜脈過濾器

K 號：K242953 · 2024-12-20

決定日期2024-12-20

產品代碼DTM

諮詢委員會履歷

決定相當於

器材摘要

KIDS Arterial Filters is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K242953. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KIDS Arterial Filters?

KIDS Arterial Filters is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K242953.

When did KIDS Arterial Filters receive FDA 510(k) clearance?

KIDS Arterial Filters received FDA 510(k) clearance on 2024-12-20, under 510(k) number K242953.

Who is the listed applicant for KIDS Arterial Filters?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIDS Arterial Filters?

The FDA product code for KIDS Arterial Filters is DTM.

其他以 Sorin Group Italia S.R.L. 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。

K253671雙階段靜脈針管 K251783啟動HCR及HCR DUAL心臟切開儲存器 K253616ProtekDilate 血管通路套件 K250610Easyflow (103-200; 103-300)；Easyflow Duo (103-210; 103-310)K250150VANGUARD 血液心肺機系統（Vanguard 4:1 血液心肺機組合）；VANGUARD 血液心肺機系統（Vanguard 4:1 血液心肺機組合帶分流）；VANGUARD 血液心肺機系統（Vanguard 4:1 血液心肺機組合迷你版）K243264DHF 0.2 血濃度濃縮器（DHF 02）；DHF 0.6 血濃度濃縮器（DHF 06）；SH 14 血濃度濃縮器（SH 14）

查看所有 24 項裝置 →

相關器械（代碼：DTM）

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。

K251744Affinity Pixie™ 動脈濾器配平衡™ 生物表面；Affinity® 優幼兒動脈血濾器Medtronic K242092微動脈過濾器Sorin Group Italia S.R.L.K231362OCS 心臟白血球濾過器TransMedics, Inc.

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。