# K093973: Trufill DCS Orbit Detachable Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: May 26, 2010 after 153 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: 1 generation back to K080967 (2008). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080967: Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II, Also Known as the Trufill DCS Orbit, Cordis Neurovascular, Inc. (2008) Summary page 1.

## Most influential descendants
- K120686: Orbit Galaxy G2 Microcoil Delivery System (2012), 1 descendant of its own
- K142429: CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable (2014), 0 descendants of its own

## Indications for use
1) The XTRASOFTTM ORBIT GALAXYTM Detachable Coil is indicated for embolizing intracranial aneurysms. 2) The Fill ORBIT GALAXYTM Detachable Coil and the Frame ORBIT GALAXYTM Detachable Coil are indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The Fill ORBIT GALAXYTM Detachable Coil and the Frame ORBIT GALAXYTM Detachable Coil are also intended for arterial and venous embolization in the peripheral vasculature.

Source page: https://510kreport.com/device/K093973
Methodology: https://510kreport.com/methodology