StrokeSENS LVO— 510(k) K212261
Substantially EquivalentCircle Neurovascular Imaging, Inc.
FDA 510(k) clearance K212261 for StrokeSENS LVO, Substantially Equivalent on 2021-10-14. Applicant: Circle Neurovascular Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Circle Neurovascular Imaging, Inc.
- Product code
- Code QAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Calgary, CA
Recent devices under product code QAS
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