# K242337: FlowGuide (FG60F); GuidionShort (GS60F)

- Pathway: 510(k) (Traditional)
- Applicant: Imds Operations B.V.
- Decided: Apr 17, 2025 after 253 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: 10 generations back to K935425 (1994). 16 ancestors in all.
No later device cites it as a predicate yet.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210110: Guidion, Imds Operations B.V. (2021) Summary page 5.

## Indications for use
The Guide extension family catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices. The Guide extension family catheters are contraindicated in vessels less than 2.5mm in diameter, vessels in the neurovasculature, and the venous system.

Source page: https://510kreport.com/device/K242337
Methodology: https://510kreport.com/methodology