Penumbra, Inc. · Class II · Cleared Apr 24, 2026
| K-number | K260599 |
| Device name | INDIGO® Aspiration System INDIGO Link |
| Applicant | Penumbra, Inc. |
| Product code | QEW |
| Device class | Class II |
| Decision date | Apr 24, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.5150 |
The INDIGO Aspiration System – INDIGO Link is a mechanical thrombectomy device designed to remove fresh, soft blood clots (emboli and thrombi) from peripheral arteries of 2.5mm or larger diameter using vacuum-assisted aspiration. INDIGO Link specifically facilitates aspiration and clot removal from peripheral arteries and is not intended for use in pulmonary arteries, coronary arteries, or the neurovasculature.
The subject device uses the same biocompatible materials, sterilization method (ethylene oxide), single-use disposable design, and shelf-life (36 months) as the predicate Pounce LP Thrombectomy System. Both devices feature appropriately sized delivery components for target vessels and employ similar mechanical operating principles for thrombus removal.
ISO 13485 (Design controls, nonconforming product, corrective and preventive actions), ISO 10993-1 (Biocompatibility evaluation for limited exposure and blood-contacting devices), and FDA guidance for medical device evaluation. Testing included dimensional inspection, radial pressure, tensile, torsion, kink resistance, corrosion, and clot removal performance testing.
The INDIGO Aspiration System – INDIGO Link is substantially equivalent to the Pounce LP Thrombectomy System predicate because both devices share the same intended use (peripheral artery thrombus removal), operating principle (mechanical aspiration), design concept, fundamental technology, and demonstrate equivalent performance across bench testing, biocompatibility, and shelf-life validation.
View the full FDA submission: accessdata.fda.gov