# K082290: Neuron Delivery Catheter 070

- Pathway: 510(k) (Special)
- Applicant: Penumbra, Inc.
- Decided: Oct 31, 2008 after 81 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: 4 generations back to K010954 (2001). 5 ancestors in all.
88 later devices descend from it; 5 cite it directly.
4 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070970: Neuron Support Catheter System, Model 5F/6F, Penumbra, Inc. (2007) Summary page 1.

## Most influential descendants
- K111380: Neuron Max System (2011), 61 descendants of its own
- K180169: EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length (2018), 27 descendants of its own
- K203764: TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform (2021), 17 descendants of its own
- K142321: Benchmark Intracranial Access System (2015), 16 descendants of its own
- K152876: Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM (2016), 13 descendants of its own

## Recalls of this device
- Sep 22, 2009 · Not classified · Z-0001-2010: Failure-- product can kink or ovalize, which may result in difficulty in catheter advancement or delivery of other devices and damage to catheter, which could lead to patient injury or death as a resu

## Indications for use
The NeuronTM Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K082290
Methodology: https://510kreport.com/methodology