# K090040: Radifocus Glidecath (or Radifocus Glidecath XP)

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Feb 6, 2009 after 31 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915414 (1992). 1 ancestor in all.
11 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915414: Terumo Angiogtaphic Catheter, Terumo Medical Corp. (1992) Summary page 1.

## Most influential descendants
- K110459: Surefire Infusion Catheter System (2011), 9 descendants of its own
- K121677: Surefire HI-Flow Microcatheter (2012), 7 descendants of its own
- K143588: Surefire Infusion System 021 (2015), 6 descendants of its own
- K160662: Surefire Infusion System (2016), 5 descendants of its own
- K171355: Surefire Precision Infusion System (2017), 4 descendants of its own

## Indications for use
The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.

Source page: https://510kreport.com/device/K090040
Methodology: https://510kreport.com/methodology