# K213398: EMBOLD Fibered Detachable Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Apr 12, 2022 after 176 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: 3 generations back to K060078 (2006). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132578: Interlock - 18 Fibered Idc Occlusion System, Boston Scientific Corp (2013) Summary page 5.

## Most influential descendants
- K230706: EMBOLD™ Soft Detachable Coil System (2023), 0 descendants of its own

## Indications for use
The EMBOLD™ Fibered Detachable Coil system is intended to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for coronary or neurovascular use.

Source page: https://510kreport.com/device/K213398
Methodology: https://510kreport.com/methodology