FDA 510(k)

ANGIOGUARD XP 脂肪栓捕获导丝，ANGIOGUARD RX 脂肪栓捕获导丝

K号: K220654 · 2022-04-06

决定日期2022-04-06

产品代码NTE

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

ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corporation. It received FDA 510(k) clearance on 2022-04-06 under 510(k) number K220654. The device is classified under product code NTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire?

ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire is a medical device that received FDA 510(k) clearance on 2022-04-06. The listed applicant is Cordis Corporation. The 510(k) number is K220654.

When did ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire receive FDA 510(k) clearance?

ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire received FDA 510(k) clearance on 2022-04-06, under 510(k) number K220654.

Who is the listed applicant for ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire?

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

What is the FDA product code for ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire?

The FDA product code for ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire is NTE.

列明Cordis Corporation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。

K212977SUPER 扭矩 MB 影像导管，带不透射线标记带 K210626SABER .035 经皮腔内血管成形术 (PTA) 扩张导管 K202167Brite Tip Radianz Guiding Sheath K201377SABERX RADIANZ 经皮腔内血管成形术扩张导管 K201333SABER .035 PTA 扩张导管 K181592RAIN 套管经桡动脉

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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。