# K182918: Ballast 088 Long Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Balt USA, LLC
- Decided: Mar 21, 2019 after 153 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 K010954 (2001). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111380: Neuron Max System, Penumbra, Inc. (2011) Summary page 4.

## Most influential descendants
- K242376: Next Generation Access Platform (2024), 0 descendants of its own

## Indications for use
The Ballast 088 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K182918
Methodology: https://510kreport.com/methodology