# K993418: Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific, Target
- Decided: Jan 21, 2000 after 112 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K951256 (1995). 24 ancestors in all.
69 later devices descend from it; 2 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962503: Guglielmi Detachable Coil, Target Therapeutics (1996) Summary page 1.
- K914786: Target Therapeutics Coils, Target Therapeutics (1992) Summary page 1.
- K971395: Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce, Target Therapeutics (1997) Summary page 1.
- K901337: Hilal Embolization Microcoil (TM), Cook, Inc. (1990) Summary page 1.
- K940982: Arterial Embolization Device (KRD), Cook, Inc. (1994) Summary page 1.

## Most influential descendants
- K033836: Hydrocoil Embolic System (Hes) (2003), 67 descendants of its own
- K041551: Modification to: Hydrocoil Embolic System (Hes) (2004), 66 descendants of its own
- K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) (2005), 65 descendants of its own
- K070656: Hydrocoil Embolic System (Hes) (2007), 36 descendants of its own
- K082461: Bare Platinum Framing Coil, Model (S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B (2008), 35 descendants of its own

## Recalls of this device
- Nov 4, 2013 · Class II · Z-0504-2014: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.

## Indications for use
The Fibered GDC is intended for embolization of vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. Fibered GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K993418
Methodology: https://510kreport.com/methodology