K231056
- 510(k) number
- K231056
- Device name
- Esperance Distal Access Catheter
- Applicant
- Wallaby Medical CA · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2024-03-08
- Date received
- 2023-04-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K231056.pdf
Official FDA record: K231056
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.