# K014041: Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as the Trufill DCS Detachable Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Neurovascular
- Decided: Mar 7, 2002 after 90 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: 5 generations back to K951256 (1995). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951256: Detachable Platinum Coil (Guglielmi Detachable Coil, GDC), Target Therapeutics (1995) Summary page 3.
- K960705: Guglielmi Detachable Coil, Target Therapeutics (1996) Summary page 3.
- K962503: Guglielmi Detachable Coil, Target Therapeutics (1996) Summary page 3.
- K971395: Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce, Target Therapeutics (1997) Summary page 3.
- K991139: Guglielmi Detachable (GDC), Boston Scientific, Target (1999) Summary page 3.
- K993415: GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant Guglielmi Detachable Coil, GDC-1, Boston Scientific, Target (2000) Summary page 3.
- K993417: GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil (GDC) (3D Shape GDC), Boston Scientific, Target (2000) Summary page 3.
- K993418: Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil, Boston Scientific, Target (2000) Summary page 3.
- K001083: Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables: 451102-4, Boston Scientific, Target (2000) Summary page 3.
- K002181: GDC Ultrasoft Coil, Boston Scientific, Target (2000) Summary page 3.

## Indications for use
The TRUFILL® DCS Detachable Coil System 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 Detachable Coil System is also intended for arterial and venous embolizations in the peripheral vasculature. The TRUFILL® DCS Detachable Syringe is indicated for use with the TRUFILL® DCS Detachable Coil.

Source page: https://510kreport.com/device/K014041
Methodology: https://510kreport.com/methodology