# K141617: Cleaner Rotational Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Rex Medical, L.P.
- Decided: Nov 14, 2014 after 150 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: 9 generations back to K954234 (1995). 27 ancestors in all.
7 later devices descend from it; 2 cite it directly.
1 of 35 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013635: Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion Length), Bacchus Vascular, Inc. (2002) Summary page 5.
- K950907: Pulse*Spray Infusion System, Angiodynamics, Div. E-Z-Em, Inc. (1995) Summary page 5.
- K091029: Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM), Rex Medical (2010) Summary page 5.
- K120346: Cleaner Rotational Thrombectomy System, Rex Medical (2012) Summary page 5.

## Most influential descendants
- K211798: Cleaner Plus Thrombectomy System (2022), 5 descendants of its own
- K223891: Cobra Catheter System (2023), 2 descendants of its own
- K252956: Helo Thrombectomy System (2025), 1 descendant of its own
- K261800: Helo Max Thrombectomy System (HEL2090) (2026), 0 descendants of its own
- K233909: Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister (2024), 0 descendants of its own

## Indications for use
The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts. The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vascular.

Source page: https://510kreport.com/device/K141617
Methodology: https://510kreport.com/methodology