FDA 510(k)

Prestige 环系统（Prestige 包装线扩展）

K号: K251383 · 2025-05-30

决定日期2025-05-30

产品代码KRD

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

Prestige Coil System (Prestige Packing Line Extension) is the device name listed in this FDA 510(k) record. The listed applicant is Balt USA, LLC. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K251383. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Prestige Coil System (Prestige Packing Line Extension)?

Prestige Coil System (Prestige Packing Line Extension) is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Balt USA, LLC. The 510(k) number is K251383.

When did Prestige Coil System (Prestige Packing Line Extension) receive FDA 510(k) clearance?

Prestige Coil System (Prestige Packing Line Extension) received FDA 510(k) clearance on 2025-05-30, under 510(k) number K251383.

Who is the listed applicant for Prestige Coil System (Prestige Packing Line Extension)?

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

What is the FDA product code for Prestige Coil System (Prestige Packing Line Extension)?

The FDA product code for Prestige Coil System (Prestige Packing Line Extension) is KRD.

列明Balt USA, 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。

K260199SLIM 微导管 K254223下一代 088 导管 K254221Optima线圈系统（OptiOne线圈系统）K252569Carrier XL Delivery Catheter K252700Optima线圈系统（Optima包装线圈系统）K243948Raptor 吸引导管；Balt 吸引管套装

查看所有 19 个设备 →

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。