# K954457: Medi-Tech Eddy Intravascular Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Tech, Inc.
- Decided: May 15, 1996 after 233 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) ZEPHYR® Infusion Catheter: named in the summary without a submission number
- (no number) Balt MAGIC™ Infusion Catheter: named in the summary without a submission number
- (no number) Venture II Intravascular Infusion Catheter: named in the summary without a submission number

## Indications for use
The EDDY™ Intravascular Infusion Catheter is intended for general Intravascular use, including neuro, peripheral, and coronary vasculature. The catheter is intended to be flow tracked in order to access distal tortuous vasculature. Once the subsclective region has been accessed, the catheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents (o be used in accordance with specifications oulined by the manufacturer.

Source page: https://510kreport.com/device/K954457
Methodology: https://510kreport.com/methodology