FDA 510(k)

Relieva UltirraNav 鼻窦球囊导管

K号: K161698 · 2016-10-24

决定日期2016-10-24

产品代码LRC

咨询委员会医疗设备监管文本描述翻译如下：关于[公司/产品名称]的监管信息： - 美国食品药品监督管理局（FDA）批准号：[510(k)编号] - 预市场批准（PMA）申请号：[PMA编号] - 临床试验注册号（NCT）：[NCT编号] - 医学文献标识符（PMID）：[PMID编号] - 产品标识符：[标识符] - 相关政策：医疗监管政策v1 - 更多信息请访问：[URL] 请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。

决定实质等同

器械摘要

Relieva UltirraNav Sinus Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2016-10-24 under 510(k) number K161698. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Relieva UltirraNav Sinus Balloon Catheter?

Relieva UltirraNav Sinus Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-10-24. The listed applicant is Acclarent, Inc.. The 510(k) number is K161698.

When did Relieva UltirraNav Sinus Balloon Catheter receive FDA 510(k) clearance?

Relieva UltirraNav Sinus Balloon Catheter received FDA 510(k) clearance on 2016-10-24, under 510(k) number K161698.

Who is the listed applicant for Relieva UltirraNav Sinus Balloon Catheter?

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

What is the FDA product code for Relieva UltirraNav Sinus Balloon Catheter?

The FDA product code for Relieva UltirraNav Sinus Balloon Catheter is LRC.

列明Acclarent, 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。

K253612Acclarent AERA 鼓室管球囊扩张系统 K230742ACCLARENT AERA 腮腺管扩张系统 K231862TruDi® 导航系统 V3（FG-2000-00）K221037TruDi 剃须刀 K201115下一代气球扩张系统 K201174TruDi 治疗器

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官方来源

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