# K013737: Modification to: 3-Lumen Duralon Occlusion Balloon

- Pathway: 510(k) (Special)
- Applicant: Telemed Systems, Inc.
- Decided: Mar 1, 2002 after 108 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
Longest line of descent: 1 generation back to K901427 (1990). 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)
- K901427: Biliary Stone Retrieval and Occlusion Balloon, Telemed Systems, Inc. (1990). Our OCR of the scanned summary read K801427, FDA’s number for Tissue-Tek Iii Mini-Rapid Processor (Miles Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “TeleMed Systems Occlusion Balloon”. Summary page 1.

## Indications for use
The TeleMed Systems 3-Lumen Occlusion Balloon Catheter is indicated for use in fluoroscopic examination of and removal of stones from the bile duct.

Source page: https://510kreport.com/device/K013737
Methodology: https://510kreport.com/methodology