FDA 510(k)

Medline ReNewal 再生美敦力達成心导管連接線 (2ACHC)

K 號：K240972 · 2024-06-07

申請人Surgical Instrument Service and Savings, Inc.

決定日期2024-06-07

產品代碼NLH

諮詢委員會履歷

決定相當於

器材摘要

Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2024-06-07 under 510(k) number K240972. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)?

Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) is a medical device that received FDA 510(k) clearance on 2024-06-07. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K240972.

When did Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) received FDA 510(k) clearance on 2024-06-07, under 510(k) number K240972.

Who is the listed applicant for Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)?

The FDA 510(k) record lists Surgical Instrument Service and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)?

The FDA product code for Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) is NLH.

其他以 Surgical Instrument Service and Savings, 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。

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相關器械（代碼：NLH）

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。

K252405美林再生處理波士頓科學動態尖端單向可導引診斷導管Surgical Instrument Service and Savings, Inc.K250772美林再生處理波士頓科學動態XT單向可導引診斷導管Surgical Instrument Service and Savings, Inc.K242225Medline ReNewal 再生 Abbott 調向診斷導管Surgical Instrument Service and Savings, Inc.K241224美林ReNewal再加工Biosense Webster Webster CS心导管，配EZ Steer技術及美林ReNewal再加工Biosense Webster Webster CS心导管，配EZ Steer技術及自動識別技術（BD710DF282CT，BD710DF282RTS，BD710FJ282RTS，BD710FJ282CT）Surgical Instrument Service and Savings Inc.(Dba Medline Ren K240826重製DECANAV™電生理導管；重製WEBSTER® Duo-Decapolar電生理導管Sterilmed, Inc.K241156美林再生再處理聖朱迪醫療反應電生理導管，至尊電生理導管（401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401Surgical Instrument Service and Savings, Inc.

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