FDA 510(k)

量子超PAC管路套件，量子超PAC心肌停搏液套件

K 號：K213540 · 2022-05-20

決定日期2022-05-20

產品代碼DWF

諮詢委員會履歷

決定相當於

器材摘要

Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set is the device name listed in this FDA 510(k) record. The listed applicant is Qura S.R.L. It received FDA 510(k) clearance on 2022-05-20 under 510(k) number K213540. 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 SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set?

Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set is a medical device that received FDA 510(k) clearance on 2022-05-20. The listed applicant is Qura S.R.L. The 510(k) number is K213540.

When did Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set receive FDA 510(k) clearance?

Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set received FDA 510(k) clearance on 2022-05-20, under 510(k) number K213540.

Who is the listed applicant for Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set?

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

What is the FDA product code for Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set?

The FDA product code for Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set is DWF.

其他以 Qura S.R.L 為申請人之記錄

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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。

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