# K113363: Angiojet Solent Dista Thrombectomy Set

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Jun 6, 2012 after 204 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K901627 (1990). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111182: Angiojet Solent Omni Thrombectomy Set, Medrad, Inc. (2011) Summary page 5.
- K072769: Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy Sets, Possis Medical, Inc. (2007) Summary page 5.

## Recalls of this device
- Jul 31, 2015 · Class II · Z-2379-2015: AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.

## Indications for use
The AngioJet Solent Dista Thrombectomy Set is intended for use with the AngloJ et Ultra Console to break apart and remove thrombus from: • upper and lower extremity peripheral arteries > 1.5mm in diameter and • for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Source page: https://510kreport.com/device/K113363
Methodology: https://510kreport.com/methodology