K222948
- 510(k) number
- K222948
- Device name
- Q Distal Access Catheter
- Applicant
- Mivi Neuroscience, Inc. MN · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2023-09-19
- Date received
- 2022-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K222948.pdf
Official FDA record: K222948
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.