FDA 510(k)

APRO 70 Swift 导管和Alembic 吸引管

K号: K243287 · 2025-02-24

决定日期2025-02-24

产品代码NRY

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

APRO 70 Swift Catheter and Alembic Aspiration Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Alembic, LLC. It received FDA 510(k) clearance on 2025-02-24 under 510(k) number K243287. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the APRO 70 Swift Catheter and Alembic Aspiration Tubing?

APRO 70 Swift Catheter and Alembic Aspiration Tubing is a medical device that received FDA 510(k) clearance on 2025-02-24. The listed applicant is Alembic, LLC. The 510(k) number is K243287.

When did APRO 70 Swift Catheter and Alembic Aspiration Tubing receive FDA 510(k) clearance?

APRO 70 Swift Catheter and Alembic Aspiration Tubing received FDA 510(k) clearance on 2025-02-24, under 510(k) number K243287.

Who is the listed applicant for APRO 70 Swift Catheter and Alembic Aspiration Tubing?

FDA 510(k)记录显示Alembic, LLC为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for APRO 70 Swift Catheter and Alembic Aspiration Tubing?

The FDA product code for APRO 70 Swift Catheter and Alembic Aspiration Tubing is NRY.

列明Alembic, LLC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。

K262391APRO 35 快速导管和阿勒姆比吸痰管 K262392APRO 35 快速导丝 K251014APRO 45 导管 K251015APRO 45 导管和Alembic 吸引管 K250962APRO 55 中间导管 K250958APRO 55 Swift 导管和Alembic 吸引管

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官方来源

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