# K973465: Latis Graft Cleaning Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: Feb 19, 1998 after 160 days
- Product code: DXE (Catheter, Embolectomy)
- 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: 1 generation back to K910372 (1991). 3 ancestors in all.
53 later devices descend from it; 2 cite it directly.
2 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910372: Intimax Thrombectomy Catheter, Applied Vascular Devices, Inc. (1991) Summary page 1.
- K950586: Avd Intimax Thrombectomy Catheter, Applied Medical Resources (1995) Summary page 1.
- K970762: Dual Lumen Embolectomy Catheter, Applied Medical Resources (1997) Summary page 1.

## Most influential descendants
- K040010: Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy) Systems (2004), 51 descendants of its own
- K143563: Infusion Aspiration Catheter System (2015), 35 descendants of its own
- K092623: F.a.S.T. System Sed and CXD (2009), 7 descendants of its own
- K163549: ClotTriever Thrombectomy System (2017), 6 descendants of its own
- K162970: FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator (2016), 6 descendants of its own

## Recalls of this device
- Oct 24, 2019 · Class I · Z-1848-2020: The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.

## Indications for use
The Applied Medical /atis™ Dual Lumen Graft Cleaning Catheter is a disposable catheter intended for use in the removal of thrombus from vascular grafts and for occlusion and infusion of fluids into a graft.

Source page: https://510kreport.com/device/K973465
Methodology: https://510kreport.com/methodology