# K983867: Fuji Catheter, Model CTH001

- Pathway: 510(k) (Traditional)
- Applicant: Windy Hill Technology, Inc.
- Decided: Jun 9, 1999 after 219 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- 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) Manan™ Galactography Kit: named in the summary without a submission number
- (no number) Manan™ Chiba Needle: named in the summary without a submission number
- (no number) Manan™ Acura Breast Localization Needle: named in the summary without a submission number

## Indications for use
The Fuji Catheter is designed to perform contrast enhanced radiography of breast milk ducts. It may also be used for the collection of cells and/or fluid for cytological analysis.

Source page: https://510kreport.com/device/K983867
Methodology: https://510kreport.com/methodology