FDA 510(k)

OBSIDIO®可塑栓塞

K号: K242507 · 2024-10-03

决定日期2024-10-03

产品代码KRD

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决定实质等同

器械摘要

OBSIDIO™ Conformable Embolic is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2024-10-03 under 510(k) number K242507. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OBSIDIO™ Conformable Embolic?

OBSIDIO™ Conformable Embolic is a medical device that received FDA 510(k) clearance on 2024-10-03. The listed applicant is Boston Scientific. The 510(k) number is K242507.

When did OBSIDIO™ Conformable Embolic receive FDA 510(k) clearance?

OBSIDIO™ Conformable Embolic received FDA 510(k) clearance on 2024-10-03, under 510(k) number K242507.

Who is the listed applicant for OBSIDIO™ Conformable Embolic?

FDA 510(k)记录显示波士顿科学公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for OBSIDIO™ Conformable Embolic?

The FDA product code for OBSIDIO™ Conformable Embolic is KRD.

列明Boston Scientific为申报人的其他记录

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