FDA 510(k)

ASEPT® Glide 腹膜引流系统

K号: K241278 · 2025-01-14

决定日期2025-01-14

产品代码PNG

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决定实质等同

器械摘要

ASEPT® Glide Peritoneal Drainage System is the device name listed in this FDA 510(k) record. The listed applicant is Pfm Medical, Inc.. It received FDA 510(k) clearance on 2025-01-14 under 510(k) number K241278. The device is classified under product code PNG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ASEPT® Glide Peritoneal Drainage System?

ASEPT® Glide Peritoneal Drainage System is a medical device that received FDA 510(k) clearance on 2025-01-14. The listed applicant is Pfm Medical, Inc.. The 510(k) number is K241278.

When did ASEPT® Glide Peritoneal Drainage System receive FDA 510(k) clearance?

ASEPT® Glide Peritoneal Drainage System received FDA 510(k) clearance on 2025-01-14, under 510(k) number K241278.

Who is the listed applicant for ASEPT® Glide Peritoneal Drainage System?

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

What is the FDA product code for ASEPT® Glide Peritoneal Drainage System?

The FDA product code for ASEPT® Glide Peritoneal Drainage System is PNG.

列明Pfm Medical, 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。

K242763JetCan® Pro 安全 Huber 针 K221779ASEPT 腹膜引流系统 K213666NuCath 压力导尿管 K201137Asept 外科手术口罩 K192802primeMidline 导管 K173114primeMidline 导管

查看所有 7 个设备 →

相关器械（代码：PNG）

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。

K241946PeritX® 1L 引流包（90-1010）；PeritX® 2L 引流包（90-2010）；PeritX® 腹膜导管包（50-9000C）；PeritX® 腹膜导管和启动包（50-9900C）；PeritX® 腹膜导管迷你包（50-9050A）；PleurX® 低轮廓导管迷你包（50-8050）；阀门盖（50-7235A）；PeritX® 阀门包（50-7272）；导管通路包（50-7280A）；可锁定引流线（50-7245A）；可锁定引流线包（50-7265A）；PleurX® 补充插入包（50-7262）；手术包（50-）Bard Peripheral Vascular, Inc.K230319Passio 泵引流系统Bearpac Medical K221779ASEPT 腹膜引流系统Pfm Medical, Inc.K212675Aspira 腹膜透析引流系统Merit Medical Systems, Inc.K201155PleurX 腹膜导管系统Care Fusion K162457Rocket留置腹膜导管（IPC）插入套件Rocket Medical Plc

官方来源

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