# K103355: GDC 360 Deteachable Coil

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Feb 16, 2011 after 92 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K951256 (1995). 28 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031049: Guglielmi Detachable Coil (GDC), Boston Scientific, Target (2003) Summary page 7.
- K042539: GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree Coil, Boston Scientific Corp (2004) Summary page 6.

## Most influential descendants
- K123338: Barricade Embolization Coil System (2013), 15 descendants of its own
- K131475: Barricade Embolization Coil System (2013), 14 descendants of its own
- K132482: Barricade Embolization Coil System (2013), 13 descendants of its own
- K140104: Barricade Embolization Coil System (2014), 12 descendants of its own
- K142513: Barricade Embolization Coil System (2014), 11 descendants of its own

## Recalls of this device
- Oct 22, 2014 · Class II · Z-0478-2015: Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
- Oct 22, 2014 · Class II · Z-0479-2015: Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
- Oct 22, 2014 · Class II · Z-0480-2015: Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.

## Indications for use
GDC® 360° Detachable Coils are intended for the endovascular embolization of- * Intracranial aneurysms * Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae * Arterial and venous embolizations in the peripheral vasculature

Source page: https://510kreport.com/device/K103355
Methodology: https://510kreport.com/methodology