# K202049: Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter

- Pathway: 510(k) (Special)
- Applicant: Applied Medical Resources Corporation
- Decided: Sep 7, 2021 after 410 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
Longest line of descent: 2 generations back to K910372 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970762: Dual Lumen Embolectomy Catheter, Applied Medical Resources (1997) Summary page 5.
- K973465: Latis Graft Cleaning Catheter, Applied Medical Resources (1998) Summary page 5.

## Indications for use
Python catheters are indicated for removal of thromboemboli from the peripheral arterial system, and for occlusion and infusion of fluids into a vessel. The Over-the-Wire Latis Graft Cleaning Catheter is indicated for the removal ofthromboemboli from vascular grafts, and for occlusion and infusion of fluids into a graft.

Source page: https://510kreport.com/device/K202049
Methodology: https://510kreport.com/methodology