# K083370: D-Clot Thrombectomy Catheter System, Model: DC 4006

- Pathway: 510(k) (Special)
- Applicant: Artegraft, Inc.
- Decided: Dec 12, 2008 after 28 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

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

Source page: https://510kreport.com/device/K083370
Methodology: https://510kreport.com/methodology