# K063254: The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Dec 7, 2006 after 41 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 K030963 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030963: Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as the Trufill DCS Orbit Detachable Coil System, Cordis Neurovascular, Inc. (2003) Summary page 2.

## Indications for use
The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.

Source page: https://510kreport.com/device/K063254
Methodology: https://510kreport.com/methodology