# K121785: Scepter C Occlusion Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Aug 10, 2012 after 53 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K011526 (2001). 13 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110741: Scepter C Occlusion Balloon Catheter, MicroVention, Inc. (2011) Summary page 1.
- K113698: Scepter XC Occlusion Balloon Catheter, MicroVention, Inc. (2012) Summary page 3.
- K083343: Headway 17 Microcatheter, MicroVention, Inc. (2008) Summary page 1.

## Most influential descendants
- K182829: Scepter Mini Occlusion Balloon Catheter (2019), 0 descendants of its own
- K183045: Eclipse 2L (2019), 0 descendants of its own

## Indications for use
For use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms. For use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials. For neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner diameter of the Scepter C/XC Balloon Catheter.

Source page: https://510kreport.com/device/K121785
Methodology: https://510kreport.com/methodology