Infusion catheters

Uni-Fuse+

by AngioDynamics, Inc.

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.

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Uni-Fuse+ models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
12401845Length 90 cm; Catheter Gauge 5 Fr; Outer Diameter 1.71 mm Not statedAvailable
12401846Outer Diameter 1.71 mm; Length 90 cm; Catheter Gauge 5 Fr Not statedAvailable
12401848Outer Diameter 1.71 mm; Catheter Gauge 5 Fr; Length 135 cm Not statedAvailable
12401849Outer Diameter 1.71 mm; Length 135 cm; Catheter Gauge 5 Fr Not statedAvailable
12401851Length 90 cm; Outer Diameter 1.43 mm; Catheter Gauge 4 Fr Not statedAvailable
12401852Length 90 cm; Catheter Gauge 4 Fr; Outer Diameter 1.43 mm Not statedAvailable
12401854Outer Diameter 1.43 mm; Length 135 cm; Catheter Gauge 4 Fr Not statedAvailable
12401855Length 135 cm; Catheter Gauge 4 Fr; Outer Diameter 1.43 mm Not statedAvailable
12401857Length 90 cm; Catheter Gauge 4 Fr; Outer Diameter 1.43 mm Not statedAvailable
12401858Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 90 cm Not statedAvailable
12401859Catheter Gauge 4 Fr; Length 135 cm; Outer Diameter 1.43 mm Not statedAvailable
12401860Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 135 cm Not statedAvailable
12401861Length 90 cm; Outer Diameter 1.71 mm; Catheter Gauge 5 Fr Not statedAvailable
12401862Outer Diameter 1.71 mm; Catheter Gauge 5 Fr; Length 90 cm Not statedAvailable
12401863Length 135 cm; Outer Diameter 1.71 mm; Catheter Gauge 5 Fr Not statedAvailable
12401864Catheter Gauge 5 Fr; Outer Diameter 1.71 mm; Length 135 cm Not statedAvailable
H787124018450Catheter Gauge 5 Fr; Length 90 cm; Outer Diameter 1.71 mm Not statedAvailable
H787124018460Outer Diameter 1.71 mm; Length 90 cm; Catheter Gauge 5 Fr Not statedAvailable
H787124018480Length 135 cm; Catheter Gauge 5 Fr; Outer Diameter 1.71 mm Not statedAvailable
H787124018490Outer Diameter 1.71 mm; Length 135 cm; Catheter Gauge 5 Fr Not statedAvailable
H787124018510Length 90 cm; Catheter Gauge 4 Fr; Outer Diameter 1.43 mm Not statedAvailable
H787124018520Length 90 cm; Outer Diameter 1.43 mm; Catheter Gauge 4 Fr Not statedAvailable
H787124018540Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 135 cm Not statedAvailable
H787124018550Outer Diameter 1.43 mm; Catheter Gauge 4 Fr; Length 135 cm Not statedAvailable
H787124018570Length 90 cm; Catheter Gauge 4 Fr; Outer Diameter 1.43 mm Not statedAvailable
H787124018580Length 90 cm; Catheter Gauge 4 Fr; Outer Diameter 1.43 mm Not statedAvailable
H787124018590Outer Diameter 1.43 mm; Length 135 cm; Catheter Gauge 4 Fr Not statedAvailable
H787124018600Catheter Gauge 4 Fr; Outer Diameter 1.43 mm; Length 135 cm Not statedAvailable
H787124018610Outer Diameter 1.71 mm; Catheter Gauge 5 Fr; Length 90 cm Not statedAvailable
H787124018620Catheter Gauge 5 Fr; Length 90 cm; Outer Diameter 1.71 mm Not statedAvailable
H787124018630Outer Diameter 1.71 mm; Length 135 cm; Catheter Gauge 5 Fr Not statedAvailable
H787124018640Outer Diameter 1.71 mm; Catheter Gauge 5 Fr; Length 135 cm Not statedAvailable

FDA clearances

  • 510(k) K202347 September 2020
  • 510(k) K192864 June 2020

Procedures that use infusion catheters

Frequently asked questions

What is Uni-Fuse+ 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 Uni-Fuse+?

Uni-Fuse+ is made by AngioDynamics, Inc.. It is listed under thrombolysis infusion catheters in our device library.

What sizes does Uni-Fuse+ come in?

Sizes listed for Uni-Fuse+: Catheter Gauge: 4–5 Fr; Outer Diameter: 1.43–1.71 mm; Length: 90–135 cm. Confirm availability with the manufacturer's instructions for use.

Is Uni-Fuse+ MRI safe?

The FDA device database entry for Uni-Fuse+ does not state its MRI safety status. Check the labeling before MRI.

Is Uni-Fuse+ FDA cleared?

Uni-Fuse+ is covered by FDA submissions K192864, K202347.

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.

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