Infusion catheters
TriNav LV Infusion System
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.
TriNav LV Infusion System 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 |
|---|---|---|---|
| TVM-25120-50 | Catheter Inner Diameter 0.025 in; Catheter Working Length 120 cm; Catheter Gauge 2.9 Fr | Not stated | Available |
| TVM-25150-50 | Catheter Gauge 2.9 Fr; Catheter Inner Diameter 0.025 in; Catheter Working Length 150 cm | Not stated | Available |
FDA clearances
- 510(k) K230957 May 2023
Procedures that use infusion catheters
Frequently asked questions
What is TriNav LV Infusion System 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 TriNav LV Infusion System?
TriNav LV Infusion System is made by Surefire Medical, Inc.. It is listed under thrombolysis infusion catheters, microcatheters in our device library.
What sizes does TriNav LV Infusion System come in?
Sizes listed for TriNav LV Infusion System: Catheter Inner Diameter: 0.03 in; Catheter Working Length: 120–150 cm; Catheter Gauge: 2.9 Fr. Confirm availability with the manufacturer's instructions for use.
Is TriNav LV Infusion System MRI safe?
The FDA device database entry for TriNav LV Infusion System does not state its MRI safety status. Check the labeling before MRI.
Is TriNav LV Infusion System FDA cleared?
TriNav LV Infusion System is covered by FDA submission K230957.
How do I contact a Surefire Medical, Inc. sales representative?
Surefire Medical, Inc. has not listed representatives on LA Vascular yet. Visit the Surefire Medical, 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.