METIC™-气道气囊导管
K号: K231818 · 2023-11-15
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决定日期2023-11-15
产品代码KTI
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
METIC™- Airway Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is M/S Meril Life Sciences Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-11-15 under 510(k) number K231818. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the METIC™- Airway Balloon Catheter?
METIC™- Airway Balloon Catheter is a medical device that received FDA 510(k) clearance on 2023-11-15. The listed applicant is M/S Meril Life Sciences Pvt. , Ltd.. The 510(k) number is K231818.
When did METIC™- Airway Balloon Catheter receive FDA 510(k) clearance?
METIC™- Airway Balloon Catheter received FDA 510(k) clearance on 2023-11-15, under 510(k) number K231818.
Who is the listed applicant for METIC™- Airway Balloon Catheter?
The FDA 510(k) record lists M/S Meril Life Sciences Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for METIC™- Airway Balloon Catheter?
The FDA product code for METIC™- Airway Balloon Catheter is KTI.
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。
相关器械（代码：KTI）
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。
K261274EchoTip Ultra® 内镜超声活检针，适用于富士胶片内窥镜；EchoTip ProCore® 内镜超声活检针，适用于富士胶片内窥镜Cook Ireland, Ltd.K251478ClearTip TBNA 类型Finemedix Co., Ltd.K254040LungFlow篮状导管Free Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass可调针，配备适配器SRA-1-01和SRA-2-01Serpex Medical, Inc.K251664一次性吸引针（NA-201SX-4021）；一次性吸引针（NA-201SX-4022）Olympus Medical Systems Corporation
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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