# K213771: Merlin Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Mivi Neurovascular, Inc.
- Decided: Jan 27, 2022 after 56 days
- Product code: DXE (Catheter, Embolectomy)
- 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: 10 generations back to K003410 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161523: INDIGO Aspiration System, Penumbra, Inc. (2016) Summary page 4.

## Indications for use
As a part of the Merlin Aspiration System, the Merlin Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi in the peripheral arterial system. As a part of the Merlin Aspiration System, the High Flow Tubing is indicated to connect the guide catheter to an aspiration pump.

Source page: https://510kreport.com/device/K213771
Methodology: https://510kreport.com/methodology