# K103008: Inzone Detachment System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Dec 10, 2010 after 59 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: 8 generations back to K951256 (1995). 34 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093142: Target Detachable Coils and Inzone Detachment System, Boston Scientific Corp (2010) Summary page 1.

## Most influential descendants
- K123803: Reverse Medical Micro Vascular Plug (MVP) System (2013), 10 descendants of its own
- K120816: Inzone Detachment System (2012), 9 descendants of its own
- K160096: InZone Detachment System (2016), 8 descendants of its own
- K133282: Reverse Medical Micro Vascular Plug (MVP) System (2013), 6 descendants of its own
- K141313: Reverse Medical Micro Vascular Plug System (2014), 5 descendants of its own

## Indications for use
Boston Scientific's InZoneTM Detachment System is intended for use with all versions of BSC Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Source page: https://510kreport.com/device/K103008
Methodology: https://510kreport.com/methodology