# K230706: EMBOLD™ Soft Detachable Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jun 27, 2023 after 105 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: 4 generations back to K060078 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213398: EMBOLD Fibered Detachable Coil System, Boston Scientific Corporation (2022) Summary page 5.

## Indications for use
The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing 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/K230706
Methodology: https://510kreport.com/methodology