FDA 510(k)

DABRA雷射系統（DABRA雷射型號RA-308及DABRA導管型號101）

K 號：K210664 · 2021-07-27

決定日期2021-07-27

產品代碼PDU

諮詢委員會履歷

決定相當於

器材摘要

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) 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 2021-07-27 under 510(k) number K210664. 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 DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)?

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) is a medical device that received FDA 510(k) clearance on 2021-07-27. The listed applicant is Ra Medical Systems,Inc. The 510(k) number is K210664.

When did DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) receive FDA 510(k) clearance?

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) received FDA 510(k) clearance on 2021-07-27, under 510(k) number K210664.

Who is the listed applicant for DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)?

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 DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)?

The FDA product code for DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) 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）K170349RA-308 激光系統，激光心臟內膜导管

相關器械（代碼：PDU）

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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