# K150964: MReye Flipper Detachable Embolization Coil and Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Dec 18, 2015 after 252 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: 6 generations back to K891688 (1989). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063619: Flipper Detachable Embolization Coils, Cook, Inc. (2006) Summary page 4.

## Indications for use
MReye Flipper Detachable Embolization Coils are intended for arterial and venous embolization in the peripheral vasculature.

Source page: https://510kreport.com/device/K150964
Methodology: https://510kreport.com/methodology