Thrombectomy devices
Prodigy Catheter
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.
Prodigy 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 |
|---|---|---|---|
| PRODIGY5F | Introducer Sheath Compatibility 5 Fr; Catheter Length 160 cm | Not stated | Available |
| PRODIGY5F | Catheter Length 160 cm; Catheter Inner Diameter 0.055 in; Outer Diameter 0.067 in | Not stated | Available |
| PRODIGY6F | Introducer Sheath Compatibility 6 Fr; Catheter Length 137 cm | Not stated | Available |
| PRODIGY6F | Catheter Length 137 cm; Catheter Inner Diameter 0.071 in; Outer Diameter 0.085 in | Not stated | Available |
| PRODIGY8F | Catheter Length 90 cm; Catheter Inner Diameter 0.088 in; Outer Diameter 0.110 in | Not stated | Available |
| PRODIGY8F | Catheter Length 90 cm; Catheter Inner Diameter 0.088 in; Outer Diameter 0.110 in | Not stated | Available |
| PRODIGY8F | Introducer Sheath Compatibility 8 Fr; Catheter Length 117 cm | Not stated | Available |
| PRODIGY8F-S | Introducer Sheath Compatibility 8 Fr; Catheter Length 50 cm | Not stated | Available |
| PRODIGY8F-S | Catheter Length 50 cm; Catheter Inner Diameter 0.088 in; Outer Diameter 0.110 in | Not stated | Available |
FDA clearances
- 510(k) K214114 April 2022
Procedures that use thrombectomy devices
Frequently asked questions
What is Prodigy Catheter 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 Prodigy Catheter?
Prodigy Catheter is made by Imperative Care, Inc.. It is listed under mechanical thrombectomy devices in our device library.
What sizes does Prodigy Catheter come in?
Sizes listed for Prodigy Catheter: Catheter Length: 50–160 cm; Catheter Inner Diameter: 0.06–0.09 in; Outer Diameter: 0.07–0.11 in. Confirm availability with the manufacturer's instructions for use.
Is Prodigy Catheter MRI safe?
The FDA device database entry for Prodigy Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Prodigy Catheter FDA cleared?
Prodigy Catheter is covered by FDA submission K214114.
How do I contact a Imperative Care, Inc. sales representative?
Imperative Care, Inc. has not listed representatives on LA Vascular yet. Visit the Imperative Care, 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.