# K092666: Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Sep 30, 2009 after 30 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: 6 generations back to K951256 (1995). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021494: GDC Power Supply, Model GDC Power Supply: 451007-4, Boston Scientific, Target (2002) Summary page 1.

## 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/K092666
Methodology: https://510kreport.com/methodology