# K052004: Vascon Neuropath Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascon, LLC
- Decided: Jan 19, 2006 after 178 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cordis Guiding Catheter (ENVOY® series): named in the summary without a submission number
- (no number) VasCon Guiding Catheter (Polaris™): named in the summary without a submission number

## Recalls of this device
- Jan 11, 2013 · Class II · Z-0845-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0848-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0860-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0865-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0844-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0846-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0850-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0851-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0852-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0854-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0859-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0861-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0862-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0864-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0843-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0847-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0853-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0856-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0857-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0858-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0863-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0842-2013: Sterility of device may be compromised due to lack of packaging integrity
- Jan 11, 2013 · Class II · Z-0849-2013: Sterility of device may be compromised due to lack of package integrity
- Jan 11, 2013 · Class II · Z-0855-2013: Sterility of device may be compromised due to lack of package integrity

## Indications for use
VasCon NeuroPath TM Guiding Catheter is intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices.

Source page: https://510kreport.com/device/K052004
Methodology: https://510kreport.com/methodology