Thrombectomy devices
Pounce Thrombectomy System
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 Thrombectomy 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 |
|---|---|---|---|
| PTS-0607-7F135 | Length 135 cm | Not stated | Available |
FDA clearances
- 510(k) K192814 September 2020
Procedures that use thrombectomy devices
Frequently asked questions
What is Pounce Thrombectomy System 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 Thrombectomy System?
Pounce Thrombectomy System is made by Surmodics, Inc.. It is listed under mechanical thrombectomy devices in our device library.
What sizes does Pounce Thrombectomy System come in?
Sizes listed for Pounce Thrombectomy System: Length: 135 cm. Confirm availability with the manufacturer's instructions for use.
Is Pounce Thrombectomy System MRI safe?
The FDA device database entry for Pounce Thrombectomy System does not state its MRI safety status. Check the labeling before MRI.
Is Pounce Thrombectomy System FDA cleared?
Pounce Thrombectomy System is covered by FDA submission K192814.
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.