# K102979: Nexgen Peripheral Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Nexgen Medical Systems, Inc.
- Decided: Jan 18, 2011 after 104 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
Longest line of descent: 2 generations back to K915414 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972978: Vista Brite Tip Guiding Catheters, Cordis Corp. (1997) Summary page 1.
- K090040: Radifocus Glidecath (or Radifocus Glidecath XP), Terumo Medical Corp. (2009) Summary page 1.

## Indications for use
Intended Use: The NexGen Peripheral Guide Catheter is intended for use in the peripheral vasculature far the intravascular introduction of interventional/diagnostic devices and the injection of physician specified fluids. This device is not intended for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K102979
Methodology: https://510kreport.com/methodology