# K060904: Cleaner Rotational Thrombectomy System

- Pathway: 510(k) (Special)
- Applicant: Rex Medical, L.P.
- Decided: Apr 28, 2006 after 25 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: 6 generations back to K954234 (1995). 15 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031610: Rex Medical Cleaner Rotational Thrombectomy System, Rex Medical (2003) Summary page 1.
- K040252: Cleaner Rotational Thrombectomy System Kit, Rex Medical (2004) Summary page 1.

## Most influential descendants
- K091029: Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) (2010), 9 descendants of its own
- K120346: Cleaner Rotational Thrombectomy System (2012), 8 descendants of its own
- 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

## Indications for use
The Rex Medical CleanerTM Rotational Thrombectomy System is designed for mechanical declotting of synthetic dialysis access grafts.

Source page: https://510kreport.com/device/K060904
Methodology: https://510kreport.com/methodology