# K970762: Dual Lumen Embolectomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: Mar 28, 1997 after 25 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
54 later devices descend from it; 2 cite it directly.
2 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fogarty® Thru-Lumen Embolectomy Catheter: named in the summary without a submission number
- (no number) Applied Medical Regular Tip Embolectomy Catheter: named in the summary without a submission number

## Most influential descendants
- K973465: Latis Graft Cleaning Catheter (1998), 53 descendants of its own
- 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

## Recalls of this device
- Oct 24, 2019 · Class I · Z-1846-2020: 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.
- Oct 24, 2019 · Class I · Z-1847-2020: 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
It is indicated for the removal of arterial thromboemboli, for temporary occlusion, and for infusion of fluids. It may be used with or without a guidewire.

Source page: https://510kreport.com/device/K970762
Methodology: https://510kreport.com/methodology