# K142429: CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Dec 24, 2014 after 117 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: 12 generations back to K951256 (1995). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082739: Micrus Microcoil Delivery System, Micrus Endovascular Corporation (2008) Summary page 4.
- K083646: Micrus Microcoli System, Deltaplush, Models CPL, DPL, Micrus Endovascular Corporation (2009) Summary page 4.
- K120686: Orbit Galaxy G2 Microcoil Delivery System, Codman & Shurtleff, Inc. (2012) Summary page 4.
- K120274: Deltamaxx 18 Microcoil System, Codman and Shurtleff, Inc. (2012) Summary page 4.
- K072173: Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRC, Micrus Endovascular Corporation (2007) Summary page 4.
- K073442: Micrus Microcoil Systems, Micrus Endovascular Corporation (2008) Summary page 4.
- K032872: Micrus Microcoil System, Micrus Corp. (2003) Summary page 4.
- K062036: Micrus Microcoil System Presidio-18, Model PC4, Micrus Endovascular Corporation (2006) Summary page 4.
- K053160: Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & Che, Micrus Endovascular Corporation (2005) Summary page 4.

## Indications for use
CODMAN Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature. The DELTAMAXX Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature. The Fill ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature. The Xtrasoft ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

Source page: https://510kreport.com/device/K142429
Methodology: https://510kreport.com/methodology