# K041374: Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060

- Pathway: 510(k) (Traditional)
- Applicant: Idev Technologies, Inc.
- Decided: Mar 2, 2005 after 282 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K990829 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030504: Akonya Eliminator Mechanical Thrombectomy Device, Model EL 10060060, Idev Technologies, Inc. (2003) Summary page 5.
- K011056: Arrow-Trerotola Percutaneous Thrombolytic Device or PTD, Arrow Intl., Inc. (2001) Summary page 5.

## Indications for use
The AKénya Eliminator Plus™ Mechanical Thrombectomy Device is indicated for use in the mechanical declotting native arterio-venous (AV) fistula and synthetic dialysis grafts.

Source page: https://510kreport.com/device/K041374
Methodology: https://510kreport.com/methodology