Bullfrog Micro-Infusion Device
Bullfrog is a wire-guided catheter that delivers agents into the vessel wall or surrounding tissue through a perpendicular microneedle. A polymer actuator balloon encloses the needle during…
Bullfrog is a wire-guided catheter that delivers agents into the vessel wall or surrounding tissue through a perpendicular microneedle. A polymer actuator balloon encloses the needle during advancement to the selected vessel site.
Hydraulic actuation moves the needle through the vessel’s external elastic layer. A second compliant balloon stabilizes the catheter against the opposite wall, and applying vacuum retracts the needle into its sheath.
Listed Item
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 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.
Vessel-Size Configurations
Models cover operating vessel diameters from 2 to 16 mm. Configurations capable of treating vessels below 6 mm have specified peripheral and coronary indications; those capable only of treating vessels at least 6 mm are limited to peripheral vessels.
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.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Vascupatent Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| 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 | 2018-02-23 |
| Record revised | 2022-06-10 (version 8) |
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 |
| Distribution end date | 2018-10-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MDL12-3060-145-HT | In distribution | |
| MDL15-0616-145-HT | In distribution | |
| MDL15-4080-145-HT | In distribution | |
| MDL09-2040-145-HT-R | In distribution | |
| MDL09-2040-145-HT | In distribution | |
| MDL09-2040-145-34 | Withdrawn | |
| MDL15-4080-145 | Withdrawn | |
| MDL12-3060-145 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fountain® | Merit Medical Systems, Inc. | 154 |
| PulseSpray | AngioDynamics, Inc. | 149 |
| Merit Maestro® | Merit Medical Systems, Inc. | 143 |
| Phenom™ Catheter | Cathera, Inc. | 103 |
| UniFuse | AngioDynamics, Inc. | 84 |
| CXI | Cook Incorporated | 48 |
| Uni-Fuse+ | AngioDynamics, Inc. | 32 |
| Prowler | Medos International Sàrl | 27 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 26 |
| ICU Medical | ICU Medical, Inc | 21 |
| Cantata | Cook Incorporated | 20 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 19 |
Showing 12 of 149. All products under Catheter, Continuous Flush
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210339 | 2021-08-02 |
| K161402 | 2016-08-18 |
| K153501 | 2016-04-15 |
| K062752 | 2006-12-07 |
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.