# K073627: Flexor Evac Aspiration Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Mar 4, 2008 after 69 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- 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: 4 generations back to K010579 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061958: Medtronic Export XT Catheter, Medtronic Vascular (2006) Summary page 5.
- K063371: Pronto V3 Extraction Catheter, Model 5003, Vascular Solutions, Inc. (2006) Summary page 5.

## Indications for use
Intended for removal of fresh, soft thrombi/emboli from the peripheral arterial system.

Source page: https://510kreport.com/device/K073627
Methodology: https://510kreport.com/methodology