# K090528: Duet Long-Term Hemodialysis Catheter System, Duet Long-Term Hemodialysis Catheter System Catheter Repair Kit

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: May 28, 2009 after 90 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K981994 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981125: Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6, Medical Components, Inc. (1999) Summary page 1.
- K033294: Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with Microintroducer, C.R. Bard, Inc. (2003) Summary page 1.

## Indications for use
The DuetTM Long-Term Hemodialysis Catheter System is indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. The catheters may be inserted percutaneously into the internal jugular vein, subclavian or external jugular vein. To replace Extension Leg Assembly where there is a minimum of 6.0 cm of viable catheter on the Duetm Long-Term Hemodialysis Catheter System.

Source page: https://510kreport.com/device/K090528
Methodology: https://510kreport.com/methodology