# K021641: XTD Thrombectomy Catheter, XX CM

- Pathway: 510(k) (Special)
- Applicant: Xtrak Medical, Inc.
- Decided: Jul 26, 2002 after 67 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- 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: 3 generations back to K901627 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013473: XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control Console, Model # CT0006001; XTD Collection Bottle, Model, Xtrak Medical, Inc. (2002) Summary page 5.

## Recalls of this device
- May 1, 2024 · Class II · Z-2213-2024: Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.

## Indications for use
For breaking apart and removing thrombus from hemodialysis access graft.

Source page: https://510kreport.com/device/K021641
Methodology: https://510kreport.com/methodology