# K163618: INDIGO Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: May 24, 2017 after 153 days
- Product code: QEX (Coronary 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: 8 generations back to K010579 (2001). 23 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161506: Penumbra Aspiration System, Penumbra, Inc. (2016) Summary page 5.

## Most influential descendants
- K180412: Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister (2018), 1 descendant of its own
- K220683: INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) (2022), 0 descendants of its own

## Indications for use
As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX 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/K163618
Methodology: https://510kreport.com/methodology