Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

StrokeSENS LVO

K-Number: K212261 · 2021-10-14

ApplicantCircle Neurovascular Imaging, Inc.
Decision Date2021-10-14
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

StrokeSENS LVO is the device name listed in this FDA 510(k) record. The listed applicant is Circle Neurovascular Imaging, Inc.. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K212261. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StrokeSENS LVO?

StrokeSENS LVO is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Circle Neurovascular Imaging, Inc.. The 510(k) number is K212261.

When did StrokeSENS LVO receive FDA 510(k) clearance?

StrokeSENS LVO received FDA 510(k) clearance on 2021-10-14, under 510(k) number K212261.

Who is the listed applicant for StrokeSENS LVO?

The FDA 510(k) record lists Circle Neurovascular Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StrokeSENS LVO?

The FDA product code for StrokeSENS LVO is QAS.

Related Devices (Code: QAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261085Rapid Vessel Occlusion (Rapid VO)iSchemaviewK260729Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI HealthK261317BriefCase-TriageAidoc Medical , Ltd.K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.K252421JLK-NCCTJLK, Inc.K253818Annalise EnterpriseHarrison-AI Medical Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑