# K152876: Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM

- Pathway: 510(k) (Traditional)
- Applicant: Tni Manufacturing, Inc.
- Decided: Jan 8, 2016 after 100 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: 6 generations back to K010954 (2001). 8 ancestors in all.
13 later devices descend from it; 3 cite it directly.
1 of 22 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 5.

## Most influential descendants
- K191551: RIST Cath Radial Access Long Sheath (2019), 6 descendants of its own
- K231393: Radical the Dude 7F Guide Catheter (2023), 2 descendants of its own
- K211990: Rist 071 Radial Access Guide Catheter (2021), 2 descendants of its own
- K191717: Route 92 Medical Sheath System (2020), 2 descendants of its own
- K172468: 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm (2017), 2 descendants of its own

## Recalls of this device
- May 2, 2018 · Class II · Z-3281-2018: The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.

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

Source page: https://510kreport.com/device/K152876
Methodology: https://510kreport.com/methodology