FDA 510(k)

Turbo-Power（2.0mm）激光动脉粥样硬化切除术导管，Turbo-Power（2.3mm）激光动脉粥样硬化切除术导管

K号: K172687 · 2017-11-27

决定日期2017-11-27

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： --- 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

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics, Inc.. It received FDA 510(k) clearance on 2017-11-27 under 510(k) number K172687. 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-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters?

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters is a medical device that received FDA 510(k) clearance on 2017-11-27. The listed applicant is Spectranetics, Inc.. The 510(k) number is K172687.

When did Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters receive FDA 510(k) clearance?

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters received FDA 510(k) clearance on 2017-11-27, under 510(k) number K172687.

Who is the listed applicant for Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters?

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

What is the FDA product code for Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters?

The FDA product code for Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters is MCW.

列明Spectranetics, 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。

K223472TightRail Guardian 电动扩张器鞘，9 法寸（575-009）；TightRail Guardian 电动扩张器鞘，11 法寸（575-011）；TightRail Guardian 电动扩张器鞘，13 法寸（575-013）K222837Turbo-Power（2.0mm）激光动脉粥样硬化切除术导管，Turbo-Power（2.3mm）激光动脉粥样硬化切除术导管 K212784TightRail 守护器电动扩张器套管 K203540Bridge 阻塞气球 K180694Turbo-Power（2.0mm）激光动脉粥样硬化切除术导管，Turbo-Power（2.3mm）激光动脉粥样硬化切除术导管 K170059Spectranetics Turbo-Elite 激光动脉粥样硬化切除术导管

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官方来源

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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。