FDA 510(k)

CORE M2血管系统

K号: K170385 · 2017-04-06

决定日期2017-04-06

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

CORE M2 Vascular System is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K170385. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CORE M2 Vascular System?

CORE M2 Vascular System is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Volcano Corporation. The 510(k) number is K170385.

When did CORE M2 Vascular System receive FDA 510(k) clearance?

CORE M2 Vascular System received FDA 510(k) clearance on 2017-04-06, under 510(k) number K170385.

Who is the listed applicant for CORE M2 Vascular System?

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

What is the FDA product code for CORE M2 Vascular System?

The FDA product code for CORE M2 Vascular System is IYO.

列明Volcano Corporation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。

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