# K172468: 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm

- Pathway: 510(k) (Traditional)
- Applicant: Inneuroco, Inc.
- Decided: Dec 6, 2017 after 113 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K010954 (2001). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152876: Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM, Tni Manufacturing, Inc. (2016) Summary page 5.

## Most influential descendants
- K193034: AXS Infinity LS Plus Long Sheath (2019), 1 descendant of its own
- K241637: Echo Intracranial Base Catheter (2024), 0 descendants of its own

## Recalls of this device
- Apr 18, 2019 · Class II · Z-1708-2019: A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.

## Indications for use
The 091 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.

Source page: https://510kreport.com/device/K172468
Methodology: https://510kreport.com/methodology