# K955110: Navarre Percutaneous Biliary Drainage

- Pathway: 510(k) (Traditional)
- Applicant: Navarre Biomedical, Ltd.
- Decided: Nov 7, 1996 after 365 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- 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) Navarre Locking Pigtail Universal Drainage Catheter: named in the summary without a submission number
- (no number) Navarre Universal Drainage Catheter: named in the summary without a submission number
- (no number) Cook Ultrathane™ Biliary Drainage Catheter: named in the summary without a submission number
- (no number) Medi-tech VTCB Biliary System™: named in the summary without a submission number

## Indications for use
The intended use of the Percutaneous Biliary Drainage Catheter is to treat patients with obstructive jaundice, sepsis, and hepatic decompensation and pre-operative decompression.

Source page: https://510kreport.com/device/K955110
Methodology: https://510kreport.com/methodology