The Mercator MedSystems® LeapFrog Micro-Infusion Device is a wire-guided, endovascular catheter that consists of a perpendicular microneedle, which is sheathed by and contained within a…
The Mercator MedSystems® LeapFrog Micro-Infusion Device is a wire-guided, endovascular catheter that consists of a perpendicular microneedle, which is sheathed by and contained within a semi-rigid polymer actuator. The device is designed to be advanced to target peripheral vasculature and hydraulically actuated to move the microneedle tip through the external elastic lamina to deliver substances to adventitial and perivascular tissues. A compliant stabilizing balloon inflates with the actuator to provide a force opposite the needle tip for proper seating of the needle. The needle is retracted within the sheathing structure by vacuuming the hydraulic actuator.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Leapfrog Micro-Infusion Device | Listed by | Mercator Medsystems, Inc., United States |
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| Establishment | Manufacturer |
| 510(k) | K210339 |
| Record published | 2023-04-17 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.