FDA 510(k)

Bard® 暫時性起搏電極針/管 (導入器)

K 號：K251186 · 2025-05-15

決定日期2025-05-15

產品代碼LDF

諮詢委員會履歷

決定相當於

器材摘要

Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K251186. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)?

Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K251186.

When did Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) receive FDA 510(k) clearance?

Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) received FDA 510(k) clearance on 2025-05-15, under 510(k) number K251186.

Who is the listed applicant for Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)?

The FDA product code for Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) is LDF.

其他以 C.R. Bard, 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：LDF）

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。

K252042同步AV II 暫時性起搏電極Swift Sync, Inc.K242863生物優質雙極起搏電極导管Bioptimal International Pte. , Ltd.K241334半浮臨時起搏電極導管，雙極，不鏽鋼電極，115公分，4Fr. (006221P)；半浮臨時起搏電極導管，雙極，不鏽鋼電極，115公分，5Fr. (006225P)；半浮臨時起搏電極導管，雙極，不鏽鋼電極，125公分，6Fr. (006241P)；半浮臨時起搏電極導管，雙極，不鏽鋼電極，125公分，7Fr. (006242P)；NBIH™臨時起搏電極導管，C.R. Bard, Inc.K241199可旋接頭 (5944RL)Shenzhen Launch Electrical Co., Ltd.K242705Streamline 雙極兒童臨時起搏導管 (6491) Streamline 雙極臨時心房起搏導管 (6492) Streamline 雙極臨時心肌起搏電極線 (6494) Streamline 雙極臨時心肌起搏導管 (6495) Streamline 雙極臨時心肌起搏導管 (6500)Medtronic, Inc.K232261TME 暫時性心肌電極Osypka AG

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