Bullfrog Micro-Infusion Device
Mercator MedSystems, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004142795 | 3004142795 | MERCATOR MEDSYSTEMS, INC. | 1 | N | 2026-01-01 | 520 McCormick Street San Leandro CA US 94577 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| M973BF101L1 | Bullfrog Micro-Infusion Device - The Mercator MedSystems Bullfrog 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 vasculature and hydraulically actuated to move the microneedle 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. | 510-614-4550 | info@mercatormed.com |
| M973BF101M1 | Bullfrog Micro-Infusion Device - The Mercator MedSystems Bullfrog 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 vasculature and hydraulically actuated to move the microneedle 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. | 510-614-4550 | info@mercatormed.com |
| M973BF101S1 | Bullfrog Micro-Infusion Device - The Mercator MedSystems Bullfrog 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 vasculature and hydraulically actuated to move the microneedle 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. | 510-614-4550 | info@mercatormed.com |
| M973BF102L1 | Bullfrog Micro-Infusion Device - The Mercator MedSystems Bullfrog 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 vasculature and hydraulically actuated to move the microneedle 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. | 510-614-4550 | info@mercatormed.com |
| M973BF102M1 | Bullfrog Micro-Infusion Device - The Mercator MedSystems Bullfrog 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 vasculature and hydraulically actuated to move the microneedle 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. | 510-614-4550 | info@mercatormed.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 62418 | 1072044766 | K210339 | Bullfrog Micro-Infusion Device | KRA | 2021-08-02 |
| 62418 | 1288689395 | K161402 | Bullfrog Micro-Infusion Device | KRA | 2016-08-18 |
| 62418 | 1220726776 | K131401 | BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER | EOQ | 2013-07-02 |
Mercator MedSystems, Inc.
MERCATOR MEDSYSTEMS, INC.
MERCATOR MEDSYSTEMS, INC.
MERCATOR MEDSYSTEMS, INC.
MERCATOR MEDSYSTEMS, INC.
2023-04-17
2021-10-24
2020-04-08
2017-01-20
2017-01-20
2017-01-20
2018-02-23
2018-02-23
2018-02-23
2020-04-08
2017-01-20