# K031610: Rex Medical Cleaner Rotational Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Rex Medical
- Decided: May 27, 2003 after 5 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970080 (1997). 3 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990829: Arrow-Trerotola  Percutaneous Thrombolytic Device or PTD, Models PT-45509 (Catheter Kit with Introducer Sheaths),PT-65, Arrow Intl., Inc. (1999) Summary page 1.
- K970080: Arrow-Trerotola PTD Catheter, Arrow Intl., Inc. (1997) Summary page 1.
- K003570: Bacchus Thrombectomy Catheter (BTC), Model BTC-0755, Bacchus Vascular, Inc. (2001) Summary page 1.

## Most influential descendants
- K033793: Cleaner II Rotational Thrombectomy System (2003), 12 descendants of its own
- K040252: Cleaner Rotational Thrombectomy System Kit (2004), 11 descendants of its own
- K060904: Cleaner Rotational Thrombectomy System (2006), 10 descendants of its own
- 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

## Recalls of this device
- Jul 12, 2004 · Not classified · Z-1315-04: The motor may fail to activate when the on/off switch is pressed.

## Indications for use
The Rex Medical CleanerTM Rotational Thrombectomy System device permits mechanical declotting in synthetic dialysis grafts.

Source page: https://510kreport.com/device/K031610
Methodology: https://510kreport.com/methodology