# K971306: FG Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Jul 14, 1997 after 97 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.
No later device cites it as a predicate yet.
0 of 3 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.
- K965181: Ces Infusion Catheter, Cordis Neurovascular, Inc. (1997) Summary page 1.
- (no number) EDDY Infusion Catheter: named in the summary without a submission number

## Indications for use
The CES FG Infusion Catheter is intended 1o be used as a mechanism for the selective infusion of various diagnostic, cmbolic and therapeutic agents into the peripheral, coronary and ncurovasculaturcs.

Source page: https://510kreport.com/device/K971306
Methodology: https://510kreport.com/methodology