# K024165: Dual-Lumen Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: Bistech, Inc.
- Decided: Jan 10, 2003 after 24 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K914181 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963252: TBAN, Boston Scientific Corp (1996) Summary page 1.
- K974642: Combicath Catheter, Plastimed Laboratoire Pharmaceutique (1998). Our reading of the summary gave K974632, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Combicath Double Plugged Telescoping Catheter”.
- (no number) Aspiration Needle Set: named in the summary without a submission number

## Indications for use
For use with a bronchoscope to deliver fluids to or withdraw fluids from the lung.

Source page: https://510kreport.com/device/K024165
Methodology: https://510kreport.com/methodology