FDA 510(k)

美林再生處理生物神威百得斯特Eco診斷超聲導管（8F，8FG，10F，10FG）

K 號：K250545 · 2025-06-05

申請人Surgical Instrument Service and Savings, Inc.

決定日期2025-06-05

產品代碼OWQ

諮詢委員會履歷

決定相當於

器材摘要

Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) 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 2025-06-05 under 510(k) number K250545. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)?

Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) is a medical device that received FDA 510(k) clearance on 2025-06-05. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K250545.

When did Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) received FDA 510(k) clearance on 2025-06-05, under 510(k) number K250545.

Who is the listed applicant for Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)?

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 Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)?

The FDA product code for Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) is OWQ.

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。

K250314Medline ReNewal 再生 Abbott Agilis Nxt 可導引引入器 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 K250772美林再生處理波士頓科學動態XT單向可導引診斷導管 K243101Medline ReNewal 再生處理西门子 ACUSON AcuNav 10F 超聲波導管（適用於西门子系統）（08255790）；Medline ReNewal 再生處理西门子 ACUSON AcuNav 10F 超聲波導管（適用於 GE 系統）（10043342）K242225Medline ReNewal 再生 Abbott 調向診斷導管 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, 401

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相關器械（代碼：OWQ）

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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