# K102714: Complex Helical 18, Multi-Loop 18, Figure 8-18, Straight 18 Fibered Platinum Coils, Vortx -18, Vortx 35 & 2D Helical

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Feb 11, 2011 after 144 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914786 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914786: Target Therapeutics Coils, Target Therapeutics (1992) Summary page 1.
- K955293: Fibered Platinum Coil, .035 Type, Target Therapeutics (1996) Summary page 1.

## Indications for use
Boston Scientific's 0.018 and 0.035 Fibered Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K102714
Methodology: https://510kreport.com/methodology