# K955534: Seque Infusion Catheter (S-25,30,35,40,45,50,60)

- Pathway: 510(k) (Traditional)
- Applicant: International Innovations, Inc.
- Decided: Aug 1, 1996 after 241 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FasTRACKER® Infusion Catheter: named in the summary without a submission number

## Indications for use
The Segue ™ Infusion Catheter is indicated for the delivery of therapeutic agents into the peripheral vasculature. It is not indicated for use in coronary or cerebral vasculature. It is not intended for use with thrombolytics. It is not intended for use with power injection pumps.

Source page: https://510kreport.com/device/K955534
Methodology: https://510kreport.com/methodology