# K080967: Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II, Also Known as the Trufill DCS Orbit

- Pathway: 510(k) (Special)
- Applicant: Cordis Neurovascular, Inc.
- Decided: May 2, 2008 after 28 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K093973: Trufill DCS Orbit Detachable Coil System (2010), 2 descendants of its own
- 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
- K123560: Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable Coil Sysem (2013), 0 descendants of its own

## Indications for use
The TRUFILL DCS ORBIT Detachable Coil is indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DCS ORBIT Detachable Coil is also intended for arterial and venous embolization in the peripheral vasculature. The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils. The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.

Source page: https://510kreport.com/device/K080967
Methodology: https://510kreport.com/methodology