# K040010: Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy) Systems

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Medical Interventional, Inc.
- Decided: Jul 19, 2004 after 196 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- 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 K832023 (1983). 14 ancestors in all.
51 later devices descend from it; 3 cite it directly.
3 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974335: Embolectomy, Irrigation - Occlusion Balloon Catheter by J-Lloyd Medical, Inc., J-Lloyd Medical, Inc. (1998) Summary page 1.
- K022145: Over the Wire Embolectomy Catheter, Model 2302, LeMaitre Vascular, Inc. (2003) Summary page 1.
- K973465: Latis Graft Cleaning Catheter, Applied Medical Resources (1998) Summary page 1.
- K991093: MSD Embolectomy Basket, Metamorphic Surgical Devices, LLC (2000) Summary page 1.
- K961883: Versa-Cath Arterial Catheter, Ideas For Medicine, Inc. (1997) Summary page 1.
- K973477: Biosensors Embolectomy Catheter, Sunscope Intl., Inc. (1998) Summary page 1.
- K971322: Core and Coil Assembly Guidewire, Lake Region Mfg., Inc. (1998) Summary page 1.
- K011084: Mandrel Guidewire Assembly, Lake Region Mfg., Inc. (2001)

## Most influential descendants
- 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
- K132281: ReVive PV (Peripheral Vasculature) Thrombectomy Device (2013), 6 descendants of its own

## Indications for use
The Genesis Medical InterventionalTM F.A.S.T.TM (Facilitated Aspiration/ Suction Thrombectomy) System is indicated for: The non-surgical removal of emboli and thrombi from blood vessels. The non-surgical removal of thrombi from synthetic grafts. Use in temporary blood vessel/graft occlusion. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft. Catheter placement over a guidewire.

Source page: https://510kreport.com/device/K040010
Methodology: https://510kreport.com/methodology