# K143563: Infusion Aspiration Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical, Inc.
- Decided: Feb 3, 2015 after 49 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: 3 generations back to K832023 (1983). 16 ancestors in all.
35 later devices descend from it; 7 cite it directly.
3 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040010: Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy) Systems, Genesis Medical Interventional, Inc. (2004) Summary page 4.
- K892410: Fogarty (R) Thru-Lumen Embolectomy Catheter, Baxter Healthcare Corp (1989) Summary page 4.
- (no number) Fogarty Venous Embolectomy Catheter: named in the summary without a submission number

## Most influential descendants
- K163549: ClotTriever Thrombectomy System (2017), 6 descendants of its own
- K162970: FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator (2016), 6 descendants of its own
- K182835: WOLF Thrombectomy Device (2019), 5 descendants of its own
- K180722: CAPERE Thrombectomy System (2018), 5 descendants of its own
- K180466: FlowTriever Retrieval/Aspiration System (2018), 5 descendants of its own

## Indications for use
The Infusion Aspiration Catheter System consists of the Infusion Wire Catheter, Aspiration Guide Catheter, and Retraction Aspirator Device. The Infusion 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 Infusion Aspiration Catheter System is intended for use in the peripheral vasculature.

Source page: https://510kreport.com/device/K143563
Methodology: https://510kreport.com/methodology