# K130192: Nextstep Retrograde

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc.
- Decided: May 10, 2013 after 105 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: 4 generations back to K010399 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites 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)
- K111900: Nextstep Antegrade Chronic Hemodialysis Catheter, Teleflexmedical, Inc. (2011) Summary page 2.
- K111117: Cannon II Plus Chronic Hemodialysis Catheter, Edge Chronic Hemodialysis Catheter, Nextstep (R) Retrograde Chronic..., Teleflexmedical, Inc. (2011)

## Most influential descendants
- K141051: Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis Catheter, Retrograde Replacement HU (2014), 0 descendants of its own

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

Source page: https://510kreport.com/device/K130192
Methodology: https://510kreport.com/methodology