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 a medical device manufactured by Circle Neurovascular Imaging, Inc.. It received FDA 510(k) clearance on 2021-10-14 under approval 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. It is manufactured by Circle Neurovascular Imaging, Inc.. The 510(k) number is K212261.
When was StrokeSENS LVO approved by the FDA?
StrokeSENS LVO received FDA 510(k) clearance on 2021-10-14, under approval number K212261.
What company makes StrokeSENS LVO?
StrokeSENS LVO is manufactured by Circle Neurovascular Imaging, Inc..
What is the FDA product code for StrokeSENS LVO?
The FDA product code for StrokeSENS LVO is QAS.
Related Devices (Code: QAS)
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.