Thrombectomy devices
Indigo 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.
Indigo 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 |
|---|---|---|---|
| CAT7DKIT-A | Length 50 cm | Not stated | Available |
| CAT7STR160KIT-A | Length 160 cm | Not stated | Available |
| CAT7XTORQ50KIT-A | Length 50 cm | Not stated | Available |
| CAT7XTORQ130KIT-A | Length 130 cm | Not stated | Available |
| CAT8STR85-A | Length 85 cm | Not stated | Available |
| CAT8STR85-S | Length 85 cm | Not stated | Available |
| CAT8STR85KIT-B | Length 85 cm | Not stated | Available |
| CAT8STR85KIT-S | Length 85 cm | Not stated | Available |
| CAT8STR115-A | Length 115 cm | Not stated | Available |
| CAT8TORQ85-A | Length 85 cm | Not stated | Available |
| CAT8TORQ85-S | Length 85 cm | Not stated | Available |
| CAT8TORQ85KIT-B | Length 85 cm | Not stated | Available |
| CAT8TORQ85KIT-S | Length 85 cm | Not stated | Available |
| CAT8XTORQ100-A | Length 100 cm | Not stated | Available |
| CAT8XTORQ115-A | Length 115 cm | Not stated | Available |
| CAT8XTORQ115-S | Length 115 cm | Not stated | Available |
| CAT8XTORQ115KIT-B | Length 115 cm | Not stated | Available |
| CAT8XTORQ115KIT-S | Length 115 cm | Not stated | Available |
| CAT8XTORQ115KIT-T | Length 115 cm | Not stated | Available |
| LITNG7XTORQ130-A | — | Not stated | Available |
| LITNG8XTORQ115 | — | Not stated | Available |
| LITNG8XTORQ115-A | — | Not stated | Available |
| LITNG8XTORQ115-S | — | Not stated | Available |
| LITNG12HTORQ100 | — | Not stated | Available |
| LITNG12HTORQ100-A | — | Not stated | Available |
| LITNG12HTORQ115 | — | Not stated | Available |
| LITNG12HTORQ115-A | — | Not stated | Available |
| LITNG12XTORQ100 | — | Not stated | Available |
| LITNG12XTORQ100-A | — | Not stated | Available |
| LITNG12XTORQ115 | — | Not stated | Available |
| LITNG12XTORQ115-A | — | Not stated | Available |
| LITNGBT6X-A | — | Not stated | Available |
| LITNGBT6X150-A | Length 150 cm | Not stated | Available |
| LITNGBT6XTX-A | Length 132 cm | Not stated | Available |
| LITNGBT6XTX150-A | Length 150 cm | Not stated | Available |
| LITNGBT7STR130-A | — | Not stated | Available |
| LITNGBT7TQ130-A | — | Not stated | Available |
| LITNGBT7XTQ130-A | — | Not stated | Available |
| LITNGFB12HT100-A | — | Not stated | Available |
| LITNGFB12HT115-A | — | Not stated | Available |
| LITNGFB12XT100-A | — | Not stated | Available |
| LITNGFB12XT115-A | — | Not stated | Available |
| LITNGFHT80BER-A | Length 80 cm; Length 105 cm | Not stated | Available |
| LITNGFHT80BER-C | Length 80 cm; Length 105 cm | Not stated | Available |
| LITNGFHT80BER-D | Length 80 cm; Length 100 cm | Not stated | Available |
| LITNGFHT80H1-A | Length 80 cm; Length 105 cm | Not stated | Available |
| LITNGFHT80H1-D | Length 80 cm; Length 100 cm | Not stated | Available |
| LITNGFHT80H1-E | Length 80 cm; Length 100 cm | Not stated | Available |
| LITNGFHT100BER-A | Length 100 cm; Length 135 cm | Not stated | Available |
| LITNGFHT100BER-C | Length 100 cm; Length 135 cm | Not stated | Available |
| LITNGFHT100BER-D | Length 100 cm; Length 120 cm | Not stated | Available |
| LITNGFHT100H1-A | Length 100 cm; Length 135 cm | Not stated | Available |
| LITNGFHT100H1-D | Length 100 cm; Length 120 cm | Not stated | Available |
| LITNGFHT100H1-E | Length 100 cm; Length 120 cm | Not stated | Available |
| LITNGFHT115BER-A | Length 115 cm; Length 135 cm | Not stated | Available |
| LITNGFHT115BER-C | Length 115 cm; Length 135 cm | Not stated | Available |
| LITNGFHT115BER-D | Length 115 cm; Length 135 cm | Not stated | Available |
| LITNGFHT115H1-A | Length 115 cm; Length 135 cm | Not stated | Available |
| LITNGFHT115H1-D | Length 115 cm; Length 135 cm | Not stated | Available |
| LITNGFHT115H1-E | Length 115 cm; Length 135 cm | Not stated | Available |
| LITNGFXT80BER-A | Length 80 cm; Length 105 cm | Not stated | Available |
| LITNGFXT80H1-A | Length 80 cm; Length 105 cm | Not stated | Available |
| LITNGFXT100BER-A | Length 100 cm; Length 135 cm | Not stated | Available |
| LITNGFXT100H1-A | Length 100 cm; Length 135 cm | Not stated | Available |
| LITNGFXT100H1-C | Length 100 cm; Length 135 cm | Not stated | Available |
| LITNGFXT100H1-D | Length 100 cm; Length 120 cm | Not stated | Available |
| LITNGFXT100H1-E | Length 100 cm; Length 120 cm | Not stated | Available |
| SEP7-A | Length 190 cm | Not stated | Available |
| SEP7D-A | Length 90 cm | Not stated | Available |
| SEP8-B | — | Not stated | Available |
| SEP12 | — | Not stated | Available |
| SEP12-A | — | Not stated | Available |
| SEP750-A | Length 90 cm | Not stated | Available |
| SEP7130-A | Length 175 cm | Not stated | Available |
| SEP7160-A | Length 190 cm | Not stated | Available |
FDA clearances
- 510(k) K251949 February 2026
- 510(k) K241399 June 2024
- 510(k) K240030 February 2024
- 510(k) K223186 February 2023
- 510(k) K222358 December 2022
- 510(k) K210323 February 2021
- 510(k) K210083 February 2021
- 510(k) K202821 November 2020
- 510(k) K193595 August 2020
- 510(k) K192981 May 2020
- 510(k) K200771 April 2020
- 510(k) K193244 March 2020
- 510(k) K192833 December 2019
Procedures that use thrombectomy devices
Frequently asked questions
What is Indigo 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 Indigo System?
Indigo System is made by Penumbra, Inc.. It is listed under mechanical thrombectomy devices, pulmonary embolism devices in our device library.
What sizes does Indigo System come in?
Sizes listed for Indigo System: Length: 50–190 cm. Confirm availability with the manufacturer's instructions for use.
Is Indigo System MRI safe?
The FDA device database entry for Indigo System does not state its MRI safety status. Check the labeling before MRI.
Is Indigo System FDA cleared?
Indigo System is covered by FDA submissions K241399, K192833, K200771, K223186, K193595, K193244.
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.