# K965189: Spinnaker

- Pathway: 510(k) (Traditional)
- Applicant: Target Therapeutics
- Decided: Mar 24, 1997 after 90 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- 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 K923368 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923368: Magic Infusion Catheter, Target Therapeutics (1993) Summary page 1.
- K921247: Zephyr Infusion Catheter, Target Therapeutics (1993) Summary page 1.

## Most influential descendants
- K980104: Flow Rider Flow Directed Micro Catheter (1998), 0 descendants of its own

## Indications for use
The Spinnaker is indicated for use in facilitating access through distal, tortuous vasculature, and may be used for the controlled, regional infusion of diagnostic agents, such as contrast media and Target Therapeutics' Berenstein Liquid Coil -10 in the peripheral and neuro vasculature. It is not intended for use in the coronary vasculature. The Spinnaker Infusion Catheter in Contraindicated for use with any other occlusion oils. Note: Compatibility testing has been conducted with the Berenstein Liquid Coil -10 only.

Source page: https://510kreport.com/device/K965189
Methodology: https://510kreport.com/methodology