# K063619: Flipper Detachable Embolization Coils

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Dec 20, 2006 after 15 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: 5 generations back to K891688 (1989). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993455: Flipper Detachable Embolization Coil, Cook, Inc. (2000) Summary page 1.
- K052834: Mreye Embolization Coil, Cook, Inc. (2005) Summary page 1.

## Most influential descendants
- K150964: MReye Flipper Detachable Embolization Coil and Delivery System (2015), 0 descendants of its own

## Indications for use
Used for arterial and venous embolization in the peripheral vasculature.

Source page: https://510kreport.com/device/K063619
Methodology: https://510kreport.com/methodology