# K223929: Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)

- Pathway: 510(k) (Traditional)
- Applicant: Innova Vascular, Inc.
- Decided: Jun 1, 2023 after 153 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: 5 generations back to K183198 (2018). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211013: FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24, Inari Medical, Inc. (2021) Summary page 4.

## Most influential descendants
- K232730: Aventus Thrombectomy System (2023), 0 descendants of its own

## Indications for use
The Laguna Thrombectomy System is indicated for: * The non-surgical removal of emboli and thrombi from blood vessels. * Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Laguna Thrombectomy System is intended for use in the peripheral vasculature. The Malibu Aspiration Catheter™ System is indicated for: * The non-surgical removal of emboli and thrombi from blood vessels. * Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Malibu Aspiration Catheter™ System is intended for use in the peripheral vasculature.

Source page: https://510kreport.com/device/K223929
Methodology: https://510kreport.com/methodology