# K183045: Eclipse 2L

- Pathway: 510(k) (Traditional)
- Applicant: Balt USA, LLC
- Decided: Apr 30, 2019 after 179 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: 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)
- K121785: Scepter C Occlusion Balloon Catheter, MicroVention, Inc. (2012) Summary page 4.

## Indications for use
The ECLIPSE 2L is indicated 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. ECLIPSE 2L is indicated for use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as embolization coils. ECLIPSE 2L is also indicated for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as DMSO based embolization materials, that have been approved for use in the neurovasculature and are compatible with the diameter of the ECLIPSE 2L.

Source page: https://510kreport.com/device/K183045
Methodology: https://510kreport.com/methodology