# K102238: Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis Catheter

- Pathway: 510(k) (Special)
- Applicant: Teleflexmedical, Inc.
- Decided: Feb 1, 2011 after 176 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 1 (0 Class I)
- 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.
3 later devices descend from it; 1 cites it directly.
2 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040260: Integral Hemodialysis Catheter, Arrow Int'L. (2004) Summary page 1.

## Most influential descendants
- K111900: Nextstep Antegrade Chronic Hemodialysis Catheter (2011), 2 descendants of its own
- K130192: Nextstep Retrograde (2013), 1 descendant of its own
- K141051: Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis Catheter, Retrograde Replacement HU (2014), 0 descendants of its own

## Recalls of this device
- Jun 28, 2011 · Not classified · Z-2883-2011: Firm has received complaints indicating breakage and/or separation of the stylet within the Arrow(R) NextStep(R) Antegrade Catheters.

## Indications for use
The Arrow® NextStepTm Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep TM Antegradle Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ)vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow® NextSte pTm Antegrade catheter is intended for use in adult patients.

Source page: https://510kreport.com/device/K102238
Methodology: https://510kreport.com/methodology