FDA 510(k)

量子灌流雙腔管31F-V1（DL31F-V1）

K 號：K241248 · 2024-05-31

決定日期2024-05-31

產品代碼DWF

諮詢委員會履歷

決定相當於

器材摘要

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical S.R.L.. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K241248. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)?

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Spectrum Medical S.R.L.. The 510(k) number is K241248.

When did Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) receive FDA 510(k) clearance?

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) received FDA 510(k) clearance on 2024-05-31, under 510(k) number K241248.

Who is the listed applicant for Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)?

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

What is the FDA product code for Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)?

The FDA product code for Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) is DWF.

其他以 Spectrum Medical 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。

K240934量子灌流血氧器 ECC VT160-E3 (VT160-E3)；量子灌流血氧器 ECC VT200-E3 (VT200-E3)；量子灌流血氧器 VT75-E3 (VT75-E3)K252541量子純流標準熱交換器中流量 1/4 W K251762量子灌流離心血泵 CP20NG 配合整合感測器（CP20V-NG）K250326量子灌流離心血泵 CP22NG 配合整合感測器（CP22V-NG）K241206量子灌流混合系統

相關器械（代碼：DWF）

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。

K260195延長式單件動脈（EOPA）3D™ 運動脈管Medtronic, Inc.K250937靜脈回流針管LivaNova USA, Inc.K260043智能反應器迷彩塗層循環離身心肺管路組（SR180C）Smart Reactors K253203後向冠狀動脈 sinus 灌注針管Medtronic, Inc.K253671雙階段靜脈針管Sorin Group Italia S.R.L.K253998清晰視內冠狀動脈分流器Medtronic, 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。