# K030504: Akonya Eliminator Mechanical Thrombectomy Device, Model EL 10060060

- Pathway: 510(k) (Traditional)
- Applicant: Idev Technologies, Inc.
- Decided: Sep 16, 2003 after 209 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: 1 generation back to K970080 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970080: Arrow-Trerotola PTD Catheter, Arrow Intl., Inc. (1997) Summary page 1.
- 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.

## Most influential descendants
- K041374: Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060 (2005), 0 descendants of its own

## Indications for use
The AK6nya EliminatorTMMechanical Thrombectomy Device is indicated for use in the mechanical declotting of synthetic dialysis grafts.

Source page: https://510kreport.com/device/K030504
Methodology: https://510kreport.com/methodology