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FDA 510(k)

RithmID-SD 可導向診斷電生理導管

K 號：K203793 · 2022-02-14

申請人Synaptic Medical Corporation
決定日期2022-02-14
產品代碼DRF
諮詢委員會履歷
決定相當於

器材摘要

RithmID-SD Steerable Diagnostic Electrophysiology Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Synaptic Medical Corporation. It received FDA 510(k) clearance on 2022-02-14 under 510(k) number K203793. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RithmID-SD Steerable Diagnostic Electrophysiology Catheter?

RithmID-SD Steerable Diagnostic Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2022-02-14. The listed applicant is Synaptic Medical Corporation. The 510(k) number is K203793.

When did RithmID-SD Steerable Diagnostic Electrophysiology Catheter receive FDA 510(k) clearance?

RithmID-SD Steerable Diagnostic Electrophysiology Catheter received FDA 510(k) clearance on 2022-02-14, under 510(k) number K203793.

Who is the listed applicant for RithmID-SD Steerable Diagnostic Electrophysiology Catheter?

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

What is the FDA product code for RithmID-SD Steerable Diagnostic Electrophysiology Catheter?

The FDA product code for RithmID-SD Steerable Diagnostic Electrophysiology Catheter is DRF.

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 Synaptic Medical Corporation 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。

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相關器械（代碼：DRF）

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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官方來源

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