# K052509: M-Bolus Embolic Microspheres

- Pathway: 510(k) (Abbreviated)
- Applicant: Scion Cardio-Vascular, Inc.
- Decided: Dec 11, 2006 after 454 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: 1 generation back to K032707 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032707: Contour SE Microspheres (Syringe), Boston Scientific Corp (2003) Summary page 1.

## Indications for use
The M-Bolus™ Embolic Microspheres are intended for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors. They may be used for vascular occlusion of vessels within the neurovascular system when presurgical devascularization is desirable.

Source page: https://510kreport.com/device/K052509
Methodology: https://510kreport.com/methodology