# K080861: Micrus Ascent Occlusion Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Micrus Endovascular Corporation
- Decided: Aug 27, 2008 after 153 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 K960806 (1996). 12 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011656: Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771, Micro Therapeutics, Inc. (2001)
- K984214: Cordis Endovascular Temporary Occlusion Balloon Catheter, Cordis Neurovascular, Inc. (1999) Summary page 1.
- K993292: Boston Scientific/Target Sentry Occlusion Balloon Catheter, Boston Scientific, Target (2000) Summary page 1.
- K060116: Micrus Courier Microcatheters, Micrus Endovascular Corporation (2006) Summary page 1.

## Most influential descendants
- K091504: Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon Catheter 4X10MM,4X15, Model BRS 00 (2009), 3 descendants of its own
- K103780: Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon Catheter 6X9 MM; Micrus Summit Occlusio (2011), 2 descendants of its own
- K142692: Occlusion Balloon Catheter (2015), 1 descendant of its own
- K180904: Sniper Infusion Catheter with Balloon Occlusion (2018), 0 descendants of its own

## Indications for use
The Micrus Ascent Occlusion Balloon Catheter is intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheter is also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.

Source page: https://510kreport.com/device/K080861
Methodology: https://510kreport.com/methodology