# K040260: Integral Hemodialysis Catheter

- Pathway: 510(k) (Special)
- Applicant: Arrow Int'L.
- Decided: Mar 5, 2004 after 30 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010399 (2001). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010399: Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC (32 CM), CC3200PC (36 CM), Diatek, Inc. (2001) Summary page 1.

## Most influential descendants
- K102238: Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis Catheter (2011), 3 descendants of its own
- 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
- K061661: Sta Cath Attachable Infision Catheter, Model STA20 (2006), 0 descendants of its own

## Recalls of this device
- Jun 10, 2008 · Not classified · Z-2281-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2271-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2285-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2272-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2278-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2273-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2283-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2276-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2280-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2282-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2277-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2275-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2274-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2284-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2279-2008: The tips may not have been adequately welded to the catheter body.

## Indications for use
The Arrow® integral catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The integral 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 integral catheter is intended for use in adult patients.

Source page: https://510kreport.com/device/K040260
Methodology: https://510kreport.com/methodology