# DEN170064: Comaneci, Comaneci Petit, Comaneci 17

- Pathway: De Novo (Direct)
- Applicant: Rapid-Medical, Ltd.
- Decided: Apr 24, 2019 after 573 days
- Product code: PUU (Temporary Coil Embolization Assist Device)
- Device class: 2
- Regulation: 21 CFR 882.5955
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial aneurysm defines the neck width as ≥ 4 mm or a dome-to-neck ratio < 2.

Source page: https://510kreport.com/device/DEN170064
Methodology: https://510kreport.com/methodology