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FDA 510(k)

DEEPVESSEL FFR

K 號：K213657 · 2022-04-01

申請人Keyamed Na, Inc.
決定日期2022-04-01
產品代碼PJA
諮詢委員會履歷
決定相當於

器材摘要

DEEPVESSEL FFR is the device name listed in this FDA 510(k) record. The listed applicant is Keyamed Na, Inc.. It received FDA 510(k) clearance on 2022-04-01 under 510(k) number K213657. The device is classified under product code PJA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DEEPVESSEL FFR?

DEEPVESSEL FFR is a medical device that received FDA 510(k) clearance on 2022-04-01. The listed applicant is Keyamed Na, Inc.. The 510(k) number is K213657.

When did DEEPVESSEL FFR receive FDA 510(k) clearance?

DEEPVESSEL FFR received FDA 510(k) clearance on 2022-04-01, under 510(k) number K213657.

Who is the listed applicant for DEEPVESSEL FFR?

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

What is the FDA product code for DEEPVESSEL FFR?

The FDA product code for DEEPVESSEL FFR is PJA.

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

相關器械（代碼：PJA）

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。

K250902心流分析HeartFlow, Inc.K213857心流分析HeartFlow, Inc.K203329心流分析HeartFlow, Inc.K190925心流 FFRct 分析HeartFlow, Inc.K182035FFRctHeartFlow, Inc.K161772FFRctHeartFlow, Inc.

官方來源

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