免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

量子智慧閉塞器 LH（左手），量子智慧閉塞器 LH（右手）

K 號：K190282 · 2019-05-24

申請人Spectrum Medical , Ltd.
決定日期2019-05-24
產品代碼DTQ
諮詢委員會履歷
決定相當於

器材摘要

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2019-05-24 under 510(k) number K190282. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)?

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) is a medical device that received FDA 510(k) clearance on 2019-05-24. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K190282.

When did Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) receive FDA 510(k) clearance?

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) received FDA 510(k) clearance on 2019-05-24, under 510(k) number K190282.

Who is the listed applicant for Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)?

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

What is the FDA product code for Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)?

The FDA product code for Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) is DTQ.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Spectrum Medical , Ltd. 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。

K240908量子微心臟停跳輸送系統；量子微心臟停跳輸送模組（QMCDM）K212657量子加熱冷卻設備K210669量子迷你通氣模組K202733量子通氣模組K202557量子工作站 12 精英K192838量子離心驅動-高壓，量子離心驅動-中壓

查看所有 12 項裝置 →

相關器械（代碼：DTQ）

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。

K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbHK221895特魯美先進灌流系統 1Terumo Cardiovascular Systems CorporationK221373Essenz HLMLivanova Deutschland, GmbHK210130Stockert S5 系統Livanova Deutschland, GmbHK202125世紀灌流系統Century Hlm, LLCK173834量子泵控制台Spectrum Medical , Ltd.

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。

↑