# K052834: Mreye Embolization Coil

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Nov 23, 2005 after 48 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.
4 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Cook Embolization Coil: named in the summary without a submission number

## Most influential descendants
- K090624: Cook Mreye Embolization Coils (2009), 1 descendant of its own
- K063619: Flipper Detachable Embolization Coils (2006), 1 descendant of its own
- K150964: MReye Flipper Detachable Embolization Coil and Delivery System (2015), 0 descendants of its own
- K150931: MReye Embolization Coils (2015), 0 descendants of its own

## Indications for use
Used for peripheral arterial and venous vessel embolization procedures.

Source page: https://510kreport.com/device/K052834
Methodology: https://510kreport.com/methodology