FDA 510(k)

Vascular Assist Occlusion Triage (VAOT) (v1.0)

K-번호: K260729 · 2026-06-18

결정일2026-06-18

제품 코드QAS

자문 위원회RA

결정Substantially Equivalent

기기 요약

Vascular Assist Occlusion Triage (VAOT) (v1.0) is the device name listed in this FDA 510(k) record. The listed applicant is GuideAI Health. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K260729. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Vascular Assist Occlusion Triage (VAOT) (v1.0)?

Vascular Assist Occlusion Triage (VAOT) (v1.0) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is GuideAI Health. The 510(k) number is K260729.

When did Vascular Assist Occlusion Triage (VAOT) (v1.0) receive FDA 510(k) clearance?

Vascular Assist Occlusion Triage (VAOT) (v1.0) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K260729.

Who is the listed applicant for Vascular Assist Occlusion Triage (VAOT) (v1.0)?

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

What is the FDA product code for Vascular Assist Occlusion Triage (VAOT) (v1.0)?

The FDA product code for Vascular Assist Occlusion Triage (VAOT) (v1.0) is QAS.

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Vascular Assist Occlusion Triage (VAOT) (v1.0)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: QAS)

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