# K111900: Nextstep Antegrade Chronic Hemodialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Aug 17, 2011 after 43 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010399 (2001). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102238: Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis Catheter, Teleflexmedical, Inc. (2011) Summary page 1.
- K111117: Cannon II Plus Chronic Hemodialysis Catheter, Edge Chronic Hemodialysis Catheter, Nextstep (R) Retrograde Chronic..., Teleflexmedical, Inc. (2011)

## Most influential descendants
- 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
- Apr 10, 2026 · Class I · Z-2159-2026: 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdr
- Feb 4, 2013 · Class II · Z-1007-2015: The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit.

## Indications for use
The Arrow® NextStep®D Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep®D Antegrade 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® NextStep®@ Antegrade catheter is intended for use in adult patients.

Source page: https://510kreport.com/device/K111900
Methodology: https://510kreport.com/methodology