FDA 510(k)

Amplatzer Piccolo®输送系统（9-PDS-04F-045）

K号: K252417 · 2025-12-17

决定日期2025-12-17

产品代码DQY

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

Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-12-17 under 510(k) number K252417. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)?

Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) is a medical device that received FDA 510(k) clearance on 2025-12-17. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K252417.

When did Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) receive FDA 510(k) clearance?

Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) received FDA 510(k) clearance on 2025-12-17, under 510(k) number K252417.

Who is the listed applicant for Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)?

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

What is the FDA product code for Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)?

The FDA product code for Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) is DQY.

列明ABBOTT MEDICAL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。

K261729EnSite™ X EP系统 K262006EnSite™ X EP系统 K261631Amplatzer TorqVue 交换系统 K253459OPTIS 移动 Next 成像系统 (1014932)；OPTIS 集成 Next 成像系统 (1014933)；Ultreon 3.0 软件升级套件 (ULTR300001)K260212EnSite™ X EP系统 K253907一次性射频消融电极

查看所有 60 个设备 →

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。