# K040328: 15.5F Jet Medical Free Flow Long-Term Coaxial Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Nov 24, 2004 after 288 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
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 no predicate by number.

## Indications for use
THE FREE FLOWTM DIALYSIS CATHETER IS INDICATED FOR USE INATTAINING LONG-TERM ACCESS FOR HEMODIALYSIS AND APHERESIS. IT MAY BE INSERTED PERCUTANEOUSLY AND PRIMARILY PLACED INTHE INTERNAL JUGULAR VEIN OF AN ADULT PATIENT. ALTERNATE INSERTION SITES INCLUDE SUBCLAVIAN VEIN AS REQUIRED. THE CURVED FREE-FLOWTM CATHETER IS INTENDED FOR INTERNAL JUGULAR VEIN INSERTION. THIS CATHETER IS INDICATED FOR A DURATION NOT TO EXCEED (12) MONTHS.

Source page: https://510kreport.com/device/K040328
Methodology: https://510kreport.com/methodology