# K974067: Fountain Infusion  Catheter  and Occluding Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Feb 27, 1998 after 123 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904788 (1990). 2 ancestors in all.
101 later devices descend from it; 6 cite it directly.
2 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961763: Pulse*Spray Infusion System, Angiodynamics, Div. E-Z-Em, Inc. (1996)
- K904788: Mewissen Catheter, Boston Scientific Corp (1990) Summary page 5.
- (no number) Multi-Sideport Catheter Infusion Set: named in the summary without a submission number

## Most influential descendants
- K981417: Squirt Fluid Delivery System (1998), 95 descendants of its own
- K013635: Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion Length) (2002), 75 descendants of its own
- K021958: Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM Catheter Length 10CM Infusion H (2002), 57 descendants of its own
- K023514: Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length) (2002), 56 descendants of its own
- K030637: Ekos Peripheral Infusion System (2003), 50 descendants of its own

## Recalls of this device
- Jan 6, 2010 · Not classified · Z-0873-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0876-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0877-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0878-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0881-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0886-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0872-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0875-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0880-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0885-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0874-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0882-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0883-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0884-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0887-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0889-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0894-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0879-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0888-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0890-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0891-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0892-2010: Infusion catheters may become brittle and break during use.
- Jan 6, 2010 · Not classified · Z-0893-2010: Infusion catheters may become brittle and break during use.

## Indications for use
The Fountain Infusion Catheter and Occluding Guide Wire will be used for the infusion of various therapeutic drugs into the peripheral vasculature' of a patient.

Source page: https://510kreport.com/device/K974067
Methodology: https://510kreport.com/methodology