# K211344: MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems

- Pathway: 510(k) (Special)
- Applicant: Medos International SARL
- Decided: May 28, 2021 after 25 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: 14 generations back to K951256 (1995). 56 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171747: MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System,  MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System, Codman & Shurtleff, Inc. (2017) Summary page 4.
- K171862: GALAXY G3 Mini Microcoil Delivery System, Codman & Shurtleff, Inc. (2017) Summary page 4.
- K150319: Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant Microcoil Delivery Systems, Codman & Shurtleff, Inc. (2015) Summary page 4.

## Most influential descendants
- 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 (2026), 0 descendants of its own

## 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 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 arterial and venous embolizations in the peripheral vasculature. The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms. 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 is also intended for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K211344
Methodology: https://510kreport.com/methodology