# K182829: Scepter Mini Occlusion Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Jul 10, 2019 after 278 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K011526 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 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 4.
- K121785: Scepter C Occlusion Balloon Catheter, MicroVention, Inc. (2012) Summary page 4.
- K113698: Scepter XC Occlusion Balloon Catheter, MicroVention, Inc. (2012) Summary page 4.

## Indications for use
The Scepter Mini Occlusion Balloon Catheter is intended: For use in the peripheral and neuro vasculature 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. For use in the peripheral vasculature for the delivery of diagnostic agents, such as contrast media, that have been approved or cleared for use in the peripheral vasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter. For neurovascular use for the delivery of diagnostic agents, such as contrast media, and liquid embolic agents that have been approved or cleared for use in the neurovasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.

Source page: https://510kreport.com/device/K182829
Methodology: https://510kreport.com/methodology