Identity
- Trade Name
- LEAPFROG Micro-Infusion Device FDA UDI
- Generic Name
- Peripheral vascular intervention infusion catheter FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- MDL18-0616-120-HT FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- BF103P FDA UDI
- Primary DI / UDI-DI
- M973BF103P1 FDA UDI
- 510(k) Number
- K210339 FDA UDI
- FDA Product Code
- KRA FDA UDI
- GMDN Term
- Peripheral vascular intervention infusion catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Peripheral vascular intervention infusion catheterCoronary artery infusion catheter
LEAPFROG Micro-Infusion Device by Mercator MedSystems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Coronary artery infusion catheter.
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- INT, K2 Microcatheter — Shanghai Kindly Medical Instruments Co., Ltd. · Class II
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- INT, K2 Microcatheter — Shanghai Kindly Medical Instruments Co., Ltd. · Class II
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Cleared under the same submission
K210339 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mercator MedSystems, Inc.
Sources (1)
- FDA UDI a7a51dbb-a88b-4aa4-bd2f-712540f5a99b 36 fields · synced Jun 9, 2026