FDA 510(k)

生命星系系統

K 號：K232132 · 2023-08-03

決定日期2023-08-03

產品代碼KFM

諮詢委員會履歷

決定相當於

器材摘要

LifeSPARC System is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K232132. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LifeSPARC System?

LifeSPARC System is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K232132.

When did LifeSPARC System receive FDA 510(k) clearance?

LifeSPARC System received FDA 510(k) clearance on 2023-08-03, under 510(k) number K232132.

Who is the listed applicant for LifeSPARC System?

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

What is the FDA product code for LifeSPARC System?

The FDA product code for LifeSPARC System is KFM.

其他以 Cardiacassist, 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。

K233736生命星系系統 K232480ProtekDuo 靜脈-靜脈針管組 K211830生命星系系統 K202751TandemHeart 泵及護理控制器 K183623LifeSPARC 泵，LifeSPARC 控制器 K181150ProtekDuo Mini 靜脈-靜脈針管組

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相關器械（代碼：KFM）

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。

K251762量子灌流離心血泵 CP20NG 配合整合感測器（CP20V-NG）Spectrum Medical S.R.L.K250326量子灌流離心血泵 CP22NG 配合整合感測器（CP22V-NG）Spectrum Medical S.R.L.K233091量子濾選式血泵CP37搭配整合感測器（CP37V-VT）；量子濾選式血泵CP22搭配整合感測器（CP22V-VT）Qura S.R.L K220842量子濾血離心血泵CP22配內置感測器，量子濾血離心血泵CP20配內置感測器Qura S.R.L K200091Capiox iCP 超速離心泵Terumo Cardiovascular Systems Corporation K201320量子純流心臟血泵 CP22 內置感測器Qura S.R.L

官方來源

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