FDA 510(k)

RA-308 激光系統，激光心臟內膜导管

K 號：K170349 · 2017-05-24

決定日期2017-05-24

產品代碼PDU

諮詢委員會履歷

決定相當於

器材摘要

RA-308 Excimer Laser System, Excimer Laser Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Ra Medical Systems,Inc. It received FDA 510(k) clearance on 2017-05-24 under 510(k) number K170349. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RA-308 Excimer Laser System, Excimer Laser Catheter?

RA-308 Excimer Laser System, Excimer Laser Catheter is a medical device that received FDA 510(k) clearance on 2017-05-24. The listed applicant is Ra Medical Systems,Inc. The 510(k) number is K170349.

When did RA-308 Excimer Laser System, Excimer Laser Catheter receive FDA 510(k) clearance?

RA-308 Excimer Laser System, Excimer Laser Catheter received FDA 510(k) clearance on 2017-05-24, under 510(k) number K170349.

Who is the listed applicant for RA-308 Excimer Laser System, Excimer Laser Catheter?

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

What is the FDA product code for RA-308 Excimer Laser System, Excimer Laser Catheter?

The FDA product code for RA-308 Excimer Laser System, Excimer Laser Catheter is PDU.

其他以 Ra Medical Systems,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。

K220544DABRA 激光系統（DABRA 激光型號 RA-308 及 DABRA 穿刺管型號 2.0）K210664DABRA雷射系統（DABRA雷射型號RA-308及DABRA導管型號101）

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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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