# K940982: Arterial Embolization Device (KRD)

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Oct 14, 1994 after 227 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
No predicates in its family tree.
70 later devices descend from it; 1 cites it directly.
0 of 71 devices in its family (counting itself) have 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
- K993418: Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil (2000), 69 descendants of its own
- K033836: Hydrocoil Embolic System (Hes) (2003), 67 descendants of its own
- K041551: Modification to: Hydrocoil Embolic System (Hes) (2004), 66 descendants of its own
- K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) (2005), 65 descendants of its own
- K070656: Hydrocoil Embolic System (Hes) (2007), 36 descendants of its own

Source page: https://510kreport.com/device/K940982
Methodology: https://510kreport.com/methodology