# K180653: Spartan eCoil System

- Pathway: 510(k) (Traditional)
- Applicant: Spartan Micro, Inc.
- Decided: Dec 4, 2018 after 266 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K951256 (1995). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162704: Axium Prime Detachable Coil System, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2017) Summary page 4.

## Indications for use
The Spartan eCoil™ System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Spartan eCoil™ System is also indicated for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K180653
Methodology: https://510kreport.com/methodology