# K021759: 14F X 55CM Ultra-Flow Catheter, Models UFS55, UFT55

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Aug 27, 2002 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: 2 generations back to K981994 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003207: Medcomp Ultra-Flow Catheter, Medical Components, Inc. (2001)
- K012562: Medcomp 14.5F Double Lumen Hemodialysis Catheter, Medical Components, Inc. (2002)

## Indications for use
THE MEDCOMP ULTRA-FLOW HEMODIALYSIS CATHETER IS INDICATED FOR USE IN ATTAINING LONG-TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN OF AN ADULT PATIENT. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.

Source page: https://510kreport.com/device/K021759
Methodology: https://510kreport.com/methodology