510(k) K231056
K231056 is an FDA 510(k) premarket notification submitted by Wallaby Medical for the device "Esperance Distal Access Catheter". The FDA issued a decision of Substantially Equivalent on March 8, 2024. The device falls under product code QJP (Catheter, Percutaneous, Neurovasculature), a Class II device regulated under 21 CFR 870.1250. Wallaby Medical has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2024
- Date Received
- April 13, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous, Neurovasculature
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- NE
- Submission Type
To provide vascular access to the neurovasculature for interventional or diagnostic procedures