Thrombectomy devices
Recana Debulking Catheter
A device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction; revascularization may also be achieved through thrombus reorientation. Also referred to as a stent retriever or clot retrieval catheter, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; it might include a guide-catheter dedicated to introduction of the wire-net. This is a single-use device.
Recana Debulking Catheter 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 |
|---|---|---|---|
| FG014 | — | Not stated | Available |
FDA clearances
- 510(k) K251185 October 2025
Procedures that use thrombectomy devices
Frequently asked questions
What is Recana Debulking Catheter used for?
A device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction; revascularization may also be achieved through thrombus reorientation. Also referred to as a stent retriever or clot retrieval catheter, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; it might include a guide-catheter dedicated to introduction of the wire-net. This is a single-use device.
Who makes Recana Debulking Catheter?
Recana Debulking Catheter is made by Intervene, Inc.. It is listed under mechanical thrombectomy devices in our device library.
What sizes does Recana Debulking Catheter come in?
The FDA device database does not list sizes for Recana Debulking Catheter. Check the instructions for use or ask a Intervene, Inc. representative.
Is Recana Debulking Catheter MRI safe?
The FDA device database entry for Recana Debulking Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Recana Debulking Catheter FDA cleared?
Recana Debulking Catheter is covered by FDA submission K251185.
How do I contact a Intervene, Inc. sales representative?
Intervene, Inc. has not listed representatives on LA Vascular yet. Visit the Intervene, 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.