# K971314: Dcat Embolectomy Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Mar 17, 1998 after 342 days
- Product code: DXE (Catheter, Embolectomy)
- 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
The ANGIODYNAMICS, Inc. DCAT System is for the percutaneous isolation and aspiration of fresh thrombus from vessels in the vascular system. Additionally, it may also be used for temporary occlusion of blood vessels, isolated infusion of fluids, and blood sampling. The ANGIODYNAMICS, Inc. Cohn Thrombectomy Catheter is intended to be used for temporary occlusion and removal of thromboemboli from native or synthetic vessels within the arterial circulation.

Source page: https://510kreport.com/device/K971314
Methodology: https://510kreport.com/methodology