# K040666: Step-Tip Chronic Hemodialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc.
- Decided: May 14, 2004 after 60 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 K010399 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040078: Cannon II Plus, Arrow International, Inc. (2004) Summary page 1.

## Indications for use
The Arrow® Step-Tip Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Step-Tip Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. It may be placed into the subclavian vein also. The Step-Tip Catheter is intended to be used only in adult patients.

Source page: https://510kreport.com/device/K040666
Methodology: https://510kreport.com/methodology