# K110741: Scepter C Occlusion Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Sep 29, 2011 after 197 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: 3 generations back to K011526 (2001). 6 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091458: Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112, 104-4113, 104-4127,104-4132,104, Ev3 Neurovascular (2009) Summary page 1.

## Most influential descendants
- K113698: Scepter XC Occlusion Balloon Catheter (2012), 3 descendants of its own
- K121785: Scepter C Occlusion Balloon Catheter (2012), 2 descendants of its own
- K182829: Scepter Mini Occlusion Balloon Catheter (2019), 0 descendants of its own
- K183045: Eclipse 2L (2019), 0 descendants of its own

## Indications for use
The Scepter C Occlusion Balloon Catheter is intended for use in the peripheral and neurovasculature where temporary occlusion is desired The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.

Source page: https://510kreport.com/device/K110741
Methodology: https://510kreport.com/methodology