FDA 510(k)

EQUINOX 气球扩张导管

K号: K190612 · 2019-12-06

决定日期2019-12-06

产品代码EZN

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决定实质等同

器械摘要

EQUINOX Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2019-12-06 under 510(k) number K190612. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EQUINOX Balloon Dilatation Catheter?

EQUINOX Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2019-12-06. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K190612.

When did EQUINOX Balloon Dilatation Catheter receive FDA 510(k) clearance?

EQUINOX Balloon Dilatation Catheter received FDA 510(k) clearance on 2019-12-06, under 510(k) number K190612.

Who is the listed applicant for EQUINOX Balloon Dilatation Catheter?

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

What is the FDA product code for EQUINOX Balloon Dilatation Catheter?

The FDA product code for EQUINOX Balloon Dilatation Catheter is EZN.

列明Dornier Medtech America, 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。

K221903Delta III Pro K213252Dornier Thulio K220871Nautilus K210394电外科附件 K201815Dornier MAGELLAN 肾盂输尿管支架 K201074Delta III Lithotripter

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相关器械（代码：EZN）

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。

K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.K220781ARMADA 肾盂输尿管扩张器套装，ARMADA 诺丁汉一步扩张器，ARMADA Amplatz 肾脏扩张器套装，ARMADA 肾脏扩张器，Glider Amplatz 套管，ARMADA 肾脏扩张器带Amplatz套管，筋膜扩张器套装，导引套管，导引导管Allwin Medical Devices, Inc.K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp.K173654输尿管扩张器套装，输尿管扩张器Cook Incorporated K180756安全导丝引导器Cook Incorporated K180028Cook 810 Set, Desilets-Hoffman 引导器套装Cook Incorporated

官方来源

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