Thrombectomy devices
Recana Introducer Sheath, 16Fr x 30cm
A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.
Recana Introducer Sheath, 16Fr x 30cm 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 |
|---|---|---|---|
| FG017 | Catheter Gauge 13 Fr; Length 30 cm | Not stated | Available |
| FG018 | Catheter Gauge 13 Fr; Length 90 cm | Not stated | Available |
| FG019 | Catheter Gauge 16 Fr; Length 30 cm | Not stated | Available |
| FG020 | Catheter Gauge 16 Fr; Length 90 cm | Not stated | Available |
FDA clearances
- 510(k) K251185 October 2025
Procedures that use thrombectomy devices
Frequently asked questions
What is Recana Introducer Sheath, 16Fr x 30cm used for?
A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.
Who makes Recana Introducer Sheath, 16Fr x 30cm?
Recana Introducer Sheath, 16Fr x 30cm is made by Intervene, Inc.. It is listed under mechanical thrombectomy devices in our device library.
What sizes does Recana Introducer Sheath, 16Fr x 30cm come in?
Sizes listed for Recana Introducer Sheath, 16Fr x 30cm: Catheter Gauge: 13–16 Fr; Length: 30–90 cm. Confirm availability with the manufacturer's instructions for use.
Is Recana Introducer Sheath, 16Fr x 30cm MRI safe?
The FDA device database entry for Recana Introducer Sheath, 16Fr x 30cm does not state its MRI safety status. Check the labeling before MRI.
Is Recana Introducer Sheath, 16Fr x 30cm FDA cleared?
Recana Introducer Sheath, 16Fr x 30cm 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.