# K120346: Cleaner Rotational Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Rex Medical
- Decided: Jun 1, 2012 after 119 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- 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 K954234 (1995). 18 ancestors in all.
8 later devices descend from it; 1 cites it directly.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091029: Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM), Rex Medical (2010) Summary page 1.
- K060904: Cleaner Rotational Thrombectomy System, Rex Medical, L.P. (2006) Summary page 1.

## Most influential descendants
- K141617: Cleaner Rotational Thrombectomy System (2014), 7 descendants of its own
- 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

## Indications for use
The Cleaner Rotational Thrombectomy System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.

Source page: https://510kreport.com/device/K120346
Methodology: https://510kreport.com/methodology