Thrombectomy devices
Indigo
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.
Indigo 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 |
|---|---|---|---|
| CATD-D | — | Not stated | Available |
| CATD-S | — | Not stated | Available |
| IAPS3 | — | Not stated | Available |
FDA clearances
- 510(k) K200771 April 2020
- 510(k) K192833 December 2019
- 510(k) K180412 May 2018
- 510(k) K180105 March 2018
Procedures that use thrombectomy devices
Frequently asked questions
What is Indigo 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 Indigo?
Indigo is made by Penumbra, Inc.. It is listed under mechanical thrombectomy devices, pulmonary embolism devices in our device library.
What sizes does Indigo come in?
The FDA device database does not list sizes for Indigo. Check the instructions for use or ask a Penumbra, Inc. representative.
Is Indigo MRI safe?
The FDA device database entry for Indigo does not state its MRI safety status. Check the labeling before MRI.
Is Indigo FDA cleared?
Indigo is covered by FDA submissions K192833, K200771, K180105, K180412.
How do I contact a Penumbra, Inc. sales representative?
Penumbra, Inc. has not listed representatives on LA Vascular yet. Visit the Penumbra, 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.