Thrombectomy devices
Pounce XL Thrombectomy
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.
Pounce XL Thrombectomy 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 |
|---|---|---|---|
| PTS-1011-7F135 | — | Not stated | Available |
FDA clearances
- 510(k) K241362 September 2024
Procedures that use thrombectomy devices
Frequently asked questions
What is Pounce XL Thrombectomy 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 Pounce XL Thrombectomy?
Pounce XL Thrombectomy is made by Surmodics, Inc.. It is listed under mechanical thrombectomy devices in our device library.
What sizes does Pounce XL Thrombectomy come in?
The FDA device database does not list sizes for Pounce XL Thrombectomy. Check the instructions for use or ask a Surmodics, Inc. representative.
Is Pounce XL Thrombectomy MRI safe?
The FDA device database entry for Pounce XL Thrombectomy does not state its MRI safety status. Check the labeling before MRI.
Is Pounce XL Thrombectomy FDA cleared?
Pounce XL Thrombectomy is covered by FDA submission K241362.
How do I contact a Surmodics, Inc. sales representative?
Surmodics, Inc. has not listed representatives on LA Vascular yet. Visit the Surmodics, 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.