# K913312: Helix Shaped Coils with Dacron Fibers, Modified

- Pathway: 510(k) (Traditional)
- Applicant: Target Therapeutics
- Decided: Nov 8, 1991 after 106 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
No predicates in its family tree.
80 later devices descend from it; 1 cites it directly.
1 of 81 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K972881: Ces Vascular Occlusion System (1998), 79 descendants of its own
- K983483: Vascular Occlusion System (1999), 78 descendants of its own
- K993455: Flipper Detachable Embolization Coil (2000), 41 descendants of its own
- K031810: Amplatzer Vascular Plug (2003), 38 descendants of its own
- K071962: Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher) (2007), 32 descendants of its own

Source page: https://510kreport.com/device/K913312
Methodology: https://510kreport.com/methodology