# K030963: Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as the Trufill DCS Orbit Detachable Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Jun 20, 2003 after 85 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TRUFILL DCS Detachable Coil System: named in the summary without a submission number

## Most influential descendants
- K123560: Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable Coil Sysem (2013), 0 descendants of its own
- K063254: The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil System (2006), 0 descendants of its own

## Indications for use
The TRUFILL DCS ORBITTM Detachable Coil is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be: a) very high risk for management by traditional operative techniques, or, b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DCS ORBITM Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature. The TRUFILL@DCS Syringe is indicated for use with the TRUFILL@family of Detachable Coils.

Source page: https://510kreport.com/device/K030963
Methodology: https://510kreport.com/methodology