Infusion catheters
UniFuse
A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.
UniFuse models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 12401801 | Length 45 cm; Outer Diameter 1.71 mm; Catheter Gauge 5 Fr | Not stated | Available |
| 12401802 | Outer Diameter 1.71 mm; Length 45 cm; Catheter Gauge 5 Fr | Not stated | Available |
| 12401803 | Length 45 cm; Catheter Gauge 5 Fr; Outer Diameter 1.71 mm | Not stated | Available |
| 12401804 | Length 45 cm; Outer Diameter 1.71 mm; Catheter Gauge 5 Fr | Not stated | Available |
| 12401805 | Catheter Gauge 5 Fr; Outer Diameter 1.71 mm; Length 90 cm | Not stated | Available |
| 12401806 | Catheter Gauge 5 Fr; Outer Diameter 1.71 mm; Length 90 cm | Not stated | Available |
| 12401807 | Outer Diameter 1.71 mm; Length 90 cm; Catheter Gauge 5 Fr | Not stated | Available |
| 12401808 | Length 90 cm; Outer Diameter 1.71 mm; Catheter Gauge 5 Fr | Not stated | Available |
| 12401809 | Length 90 cm; Outer Diameter 1.71 mm; Catheter Gauge 5 Fr | Not stated | Available |
| 12401810 | Length 90 cm; Outer Diameter 1.71 mm; Catheter Gauge 5 Fr | Not stated | Available |
| 12401811 | Length 135 cm; Outer Diameter 1.71 mm; Catheter Gauge 5 Fr | Not stated | Available |
| 12401812 | Catheter Gauge 5 Fr; Length 135 cm; Outer Diameter 1.71 mm | Not stated | Available |
| 12401813 | Length 135 cm; Catheter Gauge 5 Fr; Outer Diameter 1.71 mm | Not stated | Available |
| 12401814 | Length 135 cm; Outer Diameter 1.71 mm; Catheter Gauge 5 Fr | Not stated | Available |
| 12401815 | Catheter Gauge 5 Fr; Length 135 cm; Outer Diameter 1.71 mm | Not stated | Available |
| 12401816 | Catheter Gauge 4 Fr; Length 135 cm; Outer Diameter 1.43 mm | Not stated | Available |
| 12401817 | Catheter Gauge 4 Fr; Length 90 cm; Outer Diameter 1.43 mm | Not stated | Available |
| 12401818 | Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 90 cm | Not stated | Available |
| 12401819 | Length 90 cm; Catheter Gauge 4 Fr; Outer Diameter 1.43 mm | Not stated | Available |
| 12401820 | Catheter Gauge 4 Fr; Length 135 cm; Outer Diameter 1.43 mm | Not stated | Available |
| 12401821 | Outer Diameter 1.43 mm; Catheter Gauge 4 Fr; Length 135 cm | Not stated | Available |
| 12401822 | Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 135 cm | Not stated | Available |
| 12401823 | Outer Diameter 1.43 mm; Catheter Gauge 4 Fr; Length 45 cm | Not stated | Available |
| 12401824 | Length 45 cm; Catheter Gauge 4 Fr; Outer Diameter 1.43 mm | Not stated | Available |
| 12401825 | Catheter Gauge 4 Fr; Length 45 cm; Outer Diameter 1.43 mm | Not stated | Available |
| 12401826 | Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 45 cm | Not stated | Available |
| 12401827 | Length 45 cm; Outer Diameter 1.43 mm; Catheter Gauge 4 Fr | Not stated | Available |
| 12401828 | Length 90 cm; Outer Diameter 1.43 mm; Catheter Gauge 4 Fr | Not stated | Available |
| 12401829 | Outer Diameter 1.43 mm; Length 90 cm; Catheter Gauge 4 Fr | Not stated | Available |
| 12401830 | Length 90 cm; Catheter Gauge 4 Fr; Outer Diameter 1.43 mm | Not stated | Available |
| 12401831 | Catheter Gauge 4 Fr; Length 90 cm; Outer Diameter 1.43 mm | Not stated | Available |
| 12401832 | Catheter Gauge 4 Fr; Length 90 cm; Outer Diameter 1.43 mm | Not stated | Available |
| 12401833 | Length 135 cm; Outer Diameter 1.43 mm; Catheter Gauge 4 Fr | Not stated | Available |
| 12401834 | Outer Diameter 1.43 mm; Catheter Gauge 4 Fr; Length 135 cm | Not stated | Available |
| 12401835 | Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 135 cm | Not stated | Available |
| 12401836 | Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 135 cm | Not stated | Available |
| 12401837 | Length 135 cm; Outer Diameter 1.43 mm; Catheter Gauge 4 Fr | Not stated | Available |
| 12401838 | Outer Diameter 1.71 mm; Catheter Gauge 5 Fr; Length 45 cm | Not stated | Available |
| 12401841 | Length 45 cm; Catheter Gauge 5 Fr; Outer Diameter 1.71 mm | Not stated | Available |
| 12401842 | Outer Diameter 1.71 mm; Length 90 cm; Catheter Gauge 5 Fr | Not stated | Available |
| 12401843 | Catheter Gauge 5 Fr; Outer Diameter 1.71 mm; Length 90 cm | Not stated | Available |
| 12401844 | Catheter Gauge 5 Fr; Length 135 cm; Outer Diameter 1.71 mm | Not stated | Available |
| H787124018010 | Length 45 cm; Outer Diameter 1.71 mm; Catheter Gauge 5 Fr | Not stated | Available |
| H787124018020 | Length 45 cm; Catheter Gauge 5 Fr; Outer Diameter 1.71 mm | Not stated | Available |
| H787124018030 | Length 45 cm; Catheter Gauge 5 Fr; Outer Diameter 1.71 mm | Not stated | Available |
| H787124018040 | Catheter Gauge 5 Fr; Outer Diameter 1.71 mm; Length 45 cm | Not stated | Available |
| H787124018050 | Catheter Gauge 5 Fr; Outer Diameter 1.71 mm; Length 90 cm | Not stated | Available |
| H787124018060 | Length 90 cm; Outer Diameter 1.71 mm; Catheter Gauge 5 Fr | Not stated | Available |
| H787124018070 | Catheter Gauge 5 Fr; Outer Diameter 1.71 mm; Length 90 cm | Not stated | Available |
| H787124018080 | Length 90 cm; Outer Diameter 1.71 mm; Catheter Gauge 5 Fr | Not stated | Available |
| H787124018090 | Length 90 cm; Catheter Gauge 5 Fr; Outer Diameter 1.71 mm | Not stated | Available |
| H787124018100 | Length 90 cm; Outer Diameter 1.71 mm; Catheter Gauge 5 Fr | Not stated | Available |
| H787124018110 | Length 135 cm; Catheter Gauge 5 Fr; Outer Diameter 1.71 mm | Not stated | Available |
| H787124018120 | Outer Diameter 1.71 mm; Length 135 cm; Catheter Gauge 5 Fr | Not stated | Available |
| H787124018130 | Catheter Gauge 5 Fr; Outer Diameter 1.71 mm; Length 135 cm | Not stated | Available |
| H787124018140 | Catheter Gauge 5 Fr; Length 135 cm; Outer Diameter 1.71 mm | Not stated | Available |
| H787124018150 | Outer Diameter 1.71 mm; Catheter Gauge 5 Fr; Length 135 cm | Not stated | Available |
| H787124018160 | Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 135 cm | Not stated | Available |
| H787124018170 | Outer Diameter 1.43 mm; Length 90 cm; Catheter Gauge 4 Fr | Not stated | Available |
| H787124018180 | Catheter Gauge 4 Fr; Length 90 cm; Outer Diameter 1.43 mm | Not stated | Available |
| H787124018190 | Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 90 cm | Not stated | Available |
| H787124018200 | Length 135 cm; Catheter Gauge 4 Fr; Outer Diameter 1.43 mm | Not stated | Available |
| H787124018210 | Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 135 cm | Not stated | Available |
| H787124018220 | Catheter Gauge 4 Fr; Length 135 cm; Outer Diameter 1.43 mm | Not stated | Available |
| H787124018230 | Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 45 cm | Not stated | Available |
| H787124018240 | Outer Diameter 1.43 mm; Length 45 cm; Catheter Gauge 4 Fr | Not stated | Available |
| H787124018250 | Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 45 cm | Not stated | Available |
| H787124018260 | Outer Diameter 1.43 mm; Catheter Gauge 4 Fr; Length 45 cm | Not stated | Available |
| H787124018270 | Length 45 cm; Outer Diameter 1.43 mm; Catheter Gauge 4 Fr | Not stated | Available |
| H787124018280 | Length 90 cm; Catheter Gauge 4 Fr; Outer Diameter 1.43 mm | Not stated | Available |
| H787124018290 | Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 90 cm | Not stated | Available |
| H787124018300 | Length 90 cm; Catheter Gauge 4 Fr; Outer Diameter 1.43 mm | Not stated | Available |
| H787124018310 | Length 90 cm; Outer Diameter 1.43 mm; Catheter Gauge 4 Fr | Not stated | Available |
| H787124018320 | Catheter Gauge 4 Fr; Length 90 cm; Outer Diameter 1.43 mm | Not stated | Available |
| H787124018330 | Length 135 cm; Catheter Gauge 4 Fr; Outer Diameter 1.43 mm | Not stated | Available |
| H787124018340 | Length 135 cm; Catheter Gauge 4 Fr; Outer Diameter 1.43 mm | Not stated | Available |
| H787124018350 | Catheter Gauge 4 Fr; Length 135 cm; Outer Diameter 1.43 mm | Not stated | Available |
| H787124018360 | Length 135 cm; Outer Diameter 1.43 mm; Catheter Gauge 4 Fr | Not stated | Available |
| H787124018370 | Outer Diameter 1.43 mm; Length 135 cm; Catheter Gauge 4 Fr | Not stated | Available |
| H787124018380 | Catheter Gauge 5 Fr; Length 45 cm; Outer Diameter 1.71 mm | Not stated | Available |
| H787124018410 | Catheter Gauge 5 Fr; Length 45 cm; Outer Diameter 1.71 mm | Not stated | Available |
| H787124018420 | Catheter Gauge 5 Fr; Length 90 cm; Outer Diameter 1.71 mm | Not stated | Available |
| H787124018430 | Length 90 cm; Outer Diameter 1.71 mm; Catheter Gauge 5 Fr | Not stated | Available |
| H787124018440 | Outer Diameter 1.71 mm; Length 135 cm; Catheter Gauge 5 Fr | Not stated | Available |
FDA clearances
- 510(k) K163356 May 2017
Procedures that use infusion catheters
Frequently asked questions
What is UniFuse used for?
A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.
Who makes UniFuse?
UniFuse is made by AngioDynamics, Inc.. It is listed under thrombolysis infusion catheters in our device library.
What sizes does UniFuse come in?
Sizes listed for UniFuse: Length: 45–135 cm; Outer Diameter: 1.43–1.71 mm; Catheter Gauge: 4–5 Fr. Confirm availability with the manufacturer's instructions for use.
Is UniFuse MRI safe?
The FDA device database entry for UniFuse does not state its MRI safety status. Check the labeling before MRI.
Is UniFuse FDA cleared?
UniFuse is covered by FDA submission K163356.
How do I contact a AngioDynamics, Inc. sales representative?
AngioDynamics, Inc. has not listed representatives on LA Vascular yet. Visit the AngioDynamics, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.