# K141051: Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis Catheter, Retrograde Replacement HU

- Pathway: 510(k) (Special)
- Applicant: Arrow International, Inc.
- Decided: Jul 7, 2014 after 74 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010399 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
3 of 8 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 1.
- K130192: Nextstep Retrograde, Arrow International, Inc. (2013) Summary page 1.
- K020430: Diatek Connector Assembly Replacement Kit (Cark), Diatek, Inc. (2002) Summary page 1.

## Recalls of this device
- Apr 10, 2026 · Class I · Z-2157-2026: 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

## Indications for use
The Arrow VectorFlow Retrograde Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow VectorFlow Retrograde Chronic Hemodialysis 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 VectorFlow catheter is intended for use in adult patients. The Arrow VectorFlow Retrograde Replacement Hub Set is indicated for use in the replacement of a Arrow VectorFlow Retrograde hub connection assembly that has been damaged. The Arrow VectorFlow Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow VectorFlow Antegrade Chronic Hemodialysis 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 VectorFlow catheter is intended for use in adult patients.

Source page: https://510kreport.com/device/K141051
Methodology: https://510kreport.com/methodology