# K022221: Truflow Long-Term and Short-Term Dual-Lumen Dialysis Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Deltec, Inc.
- Decided: Jan 30, 2003 after 205 days
- Product code: MPB (Catheter, Hemodialysis, Non-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
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) MedComp Hemo-Flow Dual Lumen Dialysis Catheter: named in the summary without a submission number
- (no number) MedComp Duo-Flow Dual Lumen Catheter: named in the summary without a submission number

## Indications for use
TruFlow Long-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires long-term vascular access for hemodialysis and apheresis. The TruFlow Short-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires short-term vascular access for acute hemodialysis and apheresis. TruFlow Long-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein. TruFlow Short-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein.

Source page: https://510kreport.com/device/K022221
Methodology: https://510kreport.com/methodology