# K110055: Reverse Medical Reflex Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Reverse Medical Corporation
- Decided: Apr 5, 2011 after 85 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
No predicates in its family tree.
54 later devices descend from it; 5 cite it directly.
2 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K097007: Penumbra Neuron Intracranial Access System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K035003: HD Guide Catheter. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K161152: Navien Intracranial Support Catheter (2016), 29 descendants of its own
- K150107: Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter (2015), 29 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
- K180715: React 68 Catheter (2018), 19 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

## Indications for use
The Reverse Medical ReFleX™ Guide Catheter is indicated for the introduction of interventional devices into the peripheral, and neuro vasculature.

Source page: https://510kreport.com/device/K110055
Methodology: https://510kreport.com/methodology