# K101354: Fetch 2 Aspiration Catheter Model 109400-001

- Pathway: 510(k) (Traditional)
- Applicant: Medrad Interventional/Possis
- Decided: Jan 21, 2011 after 252 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K032763 (2003). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081989: Modification to Fetch Aspiration Catheter, Possis Medical, Inc. (2008) Summary page 5.

## Recalls of this device
- Mar 22, 2016 · Class I · Z-1342-2016: Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other

## Indications for use
The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

Source page: https://510kreport.com/device/K101354
Methodology: https://510kreport.com/methodology