# K070970: Neuron Support Catheter System, Model 5F/6F

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Aug 17, 2007 after 133 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: 3 generations back to K010954 (2001). 4 ancestors in all.
105 later devices descend from it; 9 cite it directly.
4 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053491: Penumbra Balloon Guide Catheter, Model 7.5F, Penumbra, Inc. (2006) Summary page 1.
- K010853: Guider Softip Guiding Catheter XF 5F, Boston Scientific, Target (2001) Summary page 1.

## Most influential descendants
- K082290: Neuron Delivery Catheter 070 (2008), 88 descendants of its own
- K083125: Neuron Select Catheter Size 070 (2008), 86 descendants of its own
- 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

## Recalls of this device
- Jul 1, 2009 · Not classified · Z-2313-2009: Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery'

## 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/K070970
Methodology: https://510kreport.com/methodology