# K021210: Arteria Occlusion Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Arteria Medical Science, Inc.
- Decided: Oct 28, 2002 after 194 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: 1 generation back to K990487 (1999). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990487: Equinox Occlusion Balloon System, Micro Therapeutics, Inc. (1999) Summary page 1.
- K011656: Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771, Micro Therapeutics, Inc. (2001)

## Most influential descendants
- K083300: Gore Flow Reversal System (2009), 5 descendants of its own
- K143072: ENROUTE Transcarotid Neuroprotection System (2015), 2 descendants of its own
- K153485: ENROUTE Transcarotid Neuroprotection System (2016), 1 descendant of its own
- K230402: ENROUTE® Transcarotid Neuroprotection System (2023), 0 descendants of its own
- K123156: Gore Flow Reversal System Model GFRS073 (2012), 0 descendants of its own

## Indications for use
The ArteriA Occlusion Balloon is indicated for use as an intravascular occluding catheter with an inflatable balloon tip that is used for temporary occlusion of vessels, The technique of temporary occlusion is useful in selectively stopping or controlling blood flow. The ArteriA Occlusion Balloon may be used in the peripheral and neuro-vasculature where temporary occlusion is desired during endovascular procedures.

Source page: https://510kreport.com/device/K021210
Methodology: https://510kreport.com/methodology