FDA 510(k)

快速血管闭塞（快速VO）

K号: K261085 · 2026-07-13

决定日期2026-07-13

产品代码QAS

咨询委员会RA

决定实质等同

器械摘要

Rapid Vessel Occlusion (Rapid VO) is the device name listed in this FDA 510(k) record. The listed applicant is iSchemaview. It received FDA 510(k) clearance on 2026-07-13 under 510(k) number K261085. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rapid Vessel Occlusion (Rapid VO)?

Rapid Vessel Occlusion (Rapid VO) is a medical device that received FDA 510(k) clearance on 2026-07-13. The listed applicant is iSchemaview. The 510(k) number is K261085.

When did Rapid Vessel Occlusion (Rapid VO) receive FDA 510(k) clearance?

Rapid Vessel Occlusion (Rapid VO) received FDA 510(k) clearance on 2026-07-13, under 510(k) number K261085.

Who is the listed applicant for Rapid Vessel Occlusion (Rapid VO)?

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

What is the FDA product code for Rapid Vessel Occlusion (Rapid VO)?

The FDA product code for Rapid Vessel Occlusion (Rapid VO) is QAS.

列明iSchemaview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。

K251151Rapid CTA 360

官方来源

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