RELIEVA ULTIRRA 鼻窦球囊导管
K号: K190525 · 2019-05-03
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决定日期2019-05-03
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 ULTIRRA 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 2019-05-03 under 510(k) number K190525. 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 ULTIRRA Sinus Balloon Catheter?
RELIEVA ULTIRRA Sinus Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Acclarent, Inc.. The 510(k) number is K190525.
When did RELIEVA ULTIRRA Sinus Balloon Catheter receive FDA 510(k) clearance?
RELIEVA ULTIRRA Sinus Balloon Catheter received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190525.
Who is the listed applicant for RELIEVA ULTIRRA 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 ULTIRRA Sinus Balloon Catheter?
The FDA product code for RELIEVA ULTIRRA Sinus Balloon Catheter is LRC.
相关临床试验
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。
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。
相关器械（代码：LRC）
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。
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。
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