FDA 510(k)

Bard® 临时起搏电极导管针/管 (引入器)

K号: K251186 · 2025-05-15

决定日期2025-05-15

产品代码LDF

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

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.

常见问题

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.

列明C.R. Bard, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253514明尼苏达四腔食管胃填塞管 - 18 French (0092220)；布莱克莫尔食管鼻胃管 - 20 French (0092100)；布莱克莫尔食管鼻胃管 - 16 French (0092300)K254076BD Touchless™ Plus 男女通用预润滑尿道导管套装 K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)K251864橡胶通用导管 K241334半浮动临时起搏电极导管，双极，不锈钢电极，115厘米，4Fr.（006221P）；半浮动临时起搏电极导管，双极，不锈钢电极，115厘米，5Fr.（006225P）；半浮动临时起搏电极导管，双极，不锈钢电极，125厘米，6Fr.（006241P）；半浮动临时起搏电极导管，双极，不锈钢电极，125厘米，7Fr.（006242P）；NBIH™临时起搏电极导管 K230356Aspirex™ 血栓切除术系统

查看所有 67 个设备 →

相关器械（代码：LDF）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252042同步AV II 临时起搏导管Swift Sync, Inc.K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.K241334半浮动临时起搏电极导管，双极，不锈钢电极，115厘米，4Fr.（006221P）；半浮动临时起搏电极导管，双极，不锈钢电极，115厘米，5Fr.（006225P）；半浮动临时起搏电极导管，双极，不锈钢电极，125厘米，6Fr.（006241P）；半浮动临时起搏电极导管，双极，不锈钢电极，125厘米，7Fr.（006242P）；NBIH™临时起搏电极导管C.R. Bard, Inc.K241199可旋转连接器（5944RL）Shenzhen Launch Electrical Co., Ltd.K242705Streamline 单极儿科临时起搏导线（6491）Streamline 单极临时心房起搏导线（6492）Streamline 单极临时心肌起搏导线（6494）Streamline 双极临时心肌起搏导线（6495）Streamline 单极临时心肌起搏导线（6500）Medtronic, Inc.K232261TME临时心肌电极Osypka AG

官方来源

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