# K262419: Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe (MFR100356); Micrusframe (MFR100407); Micrusframe (MFR100412); Micrusframe (MFR100509); Micrusframe (MFR100517); Micrusframe (MFR100611); Micrusframe (MFR100626); Micrusframe (MFR100713); Micrusframe (MFR100730); Micrusframe (MFR100816); Micrusframe (MFR100829); Micrusframe (MFR140225); Micrusframe (MFR140303); Micrusframe (MFR140304); Micrusframe (MFR140306); Micrusframe (MFR140406); Micrusframe (MF

- Pathway: 510(k) (Special)
- Applicant: Cerenovus, Inc.
- Decided: Aug 14, 2026 after 30 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K951256 (1995). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211344: MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems, Medos International SARL (2021) Summary page 8.

## Indications for use
MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The GALAXY G3 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The GALAXY G3 Mini Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K262419
Methodology: https://510kreport.com/methodology