# K260599: INDIGO® Aspiration System – INDIGO Link

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Apr 24, 2026 after 59 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K970657 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231022: Pounce™ Thrombectomy System, Surmodics,Inc. (2023) Summary page 5.

## Indications for use
As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. As part of the INDIGO Aspiration System, INDIGO Link is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial system ≥ 2.5mm in diameter. INDIGO Link is not intended for use in pulmonary arteries, coronaries, or the neurovasculature. As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

Source page: https://510kreport.com/device/K260599
Methodology: https://510kreport.com/methodology