FDA 510(k)

可調向心導管控制系統

K 號：K183027 · 2019-09-06

決定日期2019-09-06

產品代碼PJB

諮詢委員會履歷

決定相當於

器材摘要

Steerable catheter control system is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K183027. The device is classified under product code PJB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Steerable catheter control system?

Steerable catheter control system is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K183027.

When did Steerable catheter control system receive FDA 510(k) clearance?

Steerable catheter control system received FDA 510(k) clearance on 2019-09-06, under 510(k) number K183027.

Who is the listed applicant for Steerable catheter control system?

FDA 510(k) 記錄將Stereotaxis, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Steerable catheter control system?

The FDA product code for Steerable catheter control system is PJB.

其他以 Stereotaxis, Inc. 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。

K262744GenesisX RMN K253473同步 K251792Stereotaxis GenesisX RMN 配置 Navigant™工作站（NWS）K250590MAGiC Sweep™ EP描記電極导管 K193147Stereotaxis Genesis RMN 配置 Navigant 工作站 (NWS) 及 Cardiodrive 系統 K192775Niobe® 磁性導航系統 (MNS) 配備 Navigant 工作站 (NWS) 及 Cardiodri

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相關器械（代碼：PJB）

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。

K193147Stereotaxis Genesis RMN 配置 Navigant 工作站 (NWS) 及 Cardiodrive 系統Stereotaxis, Inc.K192775Niobe® 磁性導航系統 (MNS) 配備 Navigant 工作站 (NWS) 及 CardiodriStereotaxis, Inc.

官方來源

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