Thrombectomy devices
Indigo System Lightning Bolt 16
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 Lightning Bolt 16 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 |
|---|---|---|---|
| LITNGFB16H80H1-A | Length 80 cm; Length 100 cm | Not stated | Available |
| LITNGFB16H100H1-A | Length 100 cm; Length 120 cm | Not stated | Available |
| LITNGFB16H115H1-A | Length 115 cm; Length 135 cm | Not stated | Available |
| LITNGFB16X100H1-A | Length 100 cm; Length 120 cm | Not stated | Available |
FDA clearances
- 510(k) K252612 October 2025
Procedures that use thrombectomy devices
Frequently asked questions
What is Indigo System Lightning Bolt 16 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 Lightning Bolt 16?
Indigo System Lightning Bolt 16 is made by Penumbra, Inc.. It is listed under mechanical thrombectomy devices, pulmonary embolism devices in our device library.
What sizes does Indigo System Lightning Bolt 16 come in?
Sizes listed for Indigo System Lightning Bolt 16: Length: 80–135 cm. Confirm availability with the manufacturer's instructions for use.
Is Indigo System Lightning Bolt 16 MRI safe?
The FDA device database entry for Indigo System Lightning Bolt 16 does not state its MRI safety status. Check the labeling before MRI.
Is Indigo System Lightning Bolt 16 FDA cleared?
Indigo System Lightning Bolt 16 is covered by FDA submission K252612.
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.