FDA 510(k)

D·Kutting® LL 周围评分球囊扩张导管

K号: K242254 · 2025-04-21

决定日期2025-04-21

产品代码PNO

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

D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Dk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-21 under 510(k) number K242254. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter?

D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2025-04-21. The listed applicant is Dk Medical Technology Co., Ltd.. The 510(k) number is K242254.

When did D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter receive FDA 510(k) clearance?

D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter received FDA 510(k) clearance on 2025-04-21, under 510(k) number K242254.

Who is the listed applicant for D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter?

The FDA 510(k) record lists Dk Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter?

The FDA product code for D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter is PNO.

列明Dk Medical Technology Co., Ltd.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。

K232207D·Kutting® PTA 评分球囊扩张导管 K214009D·Kaptain PTA 高压球囊扩张导管

相关器械（代码：PNO）

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。

K261778jade分数PTA评分球囊扩张导管OrbusNeich Medical (Shenzhen) Co., Ltd.K260012UltraScore™ 焦点力PTA球囊Bard Peripheral Vascular, Inc.K243944Aperta NSE PTA球囊扩张导管Goodman Co., Ltd.K241478三楔形PTA评分球囊扩张导管Brosmed Medical Co., Ltd.K232258XO Constrain™ 经皮腔内血管成形术限制导管Transit Scientific, LLC K232013Aperta NSE PTA球囊扩张导管（AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040）Goodman Co., Ltd.

官方来源

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