# K974336: Cholangiograph Balloon Catheter by J-Lloyd Medical, Inc.

- Pathway: 510(k) (Traditional)
- Applicant: J-Lloyd Medical, Inc.
- Decided: Feb 13, 1998 after 87 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K935403 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935403: Wedge Pressure Balloon Catheter by J-Lloyd, J-Lloyd Medical, Inc. (1994) Summary page 1.

## Indications for use
The catheter is designed to provide vital diagnostic information. It is indicated for: Accessing the cystic duct and injecting radiopaque medium during Laparoscopic Cholecystomy procedures.

Source page: https://510kreport.com/device/K974336
Methodology: https://510kreport.com/methodology