FDA 510(k)

LifeSPARC 泵，LifeSPARC 控制器

K 號：K183623 · 2019-07-09

決定日期2019-07-09

產品代碼KFM

諮詢委員會履歷

決定相當於

器材摘要

LifeSPARC Pump, LifeSPARC Controller is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2019-07-09 under 510(k) number K183623. 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 Pump, LifeSPARC Controller?

LifeSPARC Pump, LifeSPARC Controller is a medical device that received FDA 510(k) clearance on 2019-07-09. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K183623.

When did LifeSPARC Pump, LifeSPARC Controller receive FDA 510(k) clearance?

LifeSPARC Pump, LifeSPARC Controller received FDA 510(k) clearance on 2019-07-09, under 510(k) number K183623.

Who is the listed applicant for LifeSPARC Pump, LifeSPARC Controller?

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 Pump, LifeSPARC Controller?

The FDA product code for LifeSPARC Pump, LifeSPARC Controller is KFM.

其他以 Cardiacassist, Inc. 為申請人之記錄

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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。

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