# K021096: X-Sizer Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Ev3 Corporation
- Decided: Sep 8, 2004 after 888 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K901627 (1990). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993816: Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FD, Baxter Edwards (2000) Summary page 1.
- K003570: Bacchus Thrombectomy Catheter (BTC), Model BTC-0755, Bacchus Vascular, Inc. (2001) Summary page 1.
- K960970: Possis Angiojet Rapid Thrombectomy  Catheter System, F105 Catheter,Model 3030C,LF140 Catheter,Model 3040C,Pump Set 3020P, Possis Medical, Inc. (1996) Summary page 1.

## Most influential descendants
- K120508: Clearlumen Thrombectomy System (2012), 3 descendants of its own
- K140296: Clearlumen Thrombectomy System (2014), 2 descendants of its own
- K161786: ClearLumen II Thrombectomy System (2016), 1 descendant of its own
- K060016: Thromcat Thrombectomy Catheter System (2006), 1 descendant of its own
- K163051: ClearLumen II Peripheral Thrombectomy System (2017), 0 descendants of its own

## Recalls of this device
- Feb 14, 2006 · Not classified · Z-1108-06: Loss of Operating Vacuum during use-It has been determined that a small percentage of X-Sizer Thrombectomy Catheter Systems from specific lots may lose operating vacuum prematurely due to a system lea
- Feb 14, 2006 · Not classified · Z-1107-06: Loss of Operating Vacuum during use-It has been determined that a small percentage of X-Sizer Thrombectomy Catheter Systems from specific lots may lose operating vacuum prematurely due to a system lea

## Indications for use
The X-SIZER Catheter System is indicated for the mechanical removal of thrombus in synthetic hemodialysis grafts.

Source page: https://510kreport.com/device/K021096
Methodology: https://510kreport.com/methodology