Turbo-Elite 激光动脉粥样硬化切除术导管
K号: K250385 · 2025-03-13
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决定日期2025-03-13
产品代码MCW
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：
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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]
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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
Turbo-Elite Laser Atherectomy Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics. It received FDA 510(k) clearance on 2025-03-13 under 510(k) number K250385. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Turbo-Elite Laser Atherectomy Catheter?
Turbo-Elite Laser Atherectomy Catheter is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is Spectranetics. The 510(k) number is K250385.
When did Turbo-Elite Laser Atherectomy Catheter receive FDA 510(k) clearance?
Turbo-Elite Laser Atherectomy Catheter received FDA 510(k) clearance on 2025-03-13, under 510(k) number K250385.
Who is the listed applicant for Turbo-Elite Laser Atherectomy Catheter?
The FDA 510(k) record lists Spectranetics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Turbo-Elite Laser Atherectomy Catheter?
The FDA product code for Turbo-Elite Laser Atherectomy Catheter is MCW.
相关临床试验
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。
相关器械（代码：MCW）
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。
K260244Auryon 激光旋切系统Eximo MedicalK250723FreedomFlow®轨道环形动脉粥样硬化系统（H6005/ 4Fr 3球配置）Cardio Flow Inc.,K242757Rotarex 激光消融系统Bard Peripheral Vascular, Inc.K242947FreedomFlow®轨道环形动脉粥样硬化系统Cardio Flow Inc.,K241553Auryon 搔刮导管 1.7mm；Auryon 搔刮导管 1.7mm，亲水涂层Eximo Medical, Ltd.K233483FreedomFlow轨道环形动脉粥样硬化系统（H6004/5Fr 3球配置）Cardio Flow Inc.,
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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