# K110936: Duraflow 2 Chronic Hemodialysis Catheter and Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Jun 10, 2011 after 67 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K981994 (1998). 16 ancestors in all.
No later device cites it as a predicate yet.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101843: Duramax Chronic Hemodialysis Catheter and Procedure Kit, AngioDynamics, Inc. (2010) Summary page 1.

## Recalls of this device
- Mar 18, 2024 · Class II · Z-1762-2024: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
- Mar 18, 2024 · Class II · Z-1765-2024: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
- Mar 18, 2024 · Class II · Z-1761-2024: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
- Mar 18, 2024 · Class II · Z-1763-2024: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
- Mar 18, 2024 · Class II · Z-1760-2024: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
- Mar 18, 2024 · Class II · Z-1764-2024: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

## Indications for use
The DuraFlow™ 2 Chronic Hemodialysis Catheter and Procedure Kit is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternative insertion sites include the subclavian vein as required. Catheters greater than 40 cm are intended for femoral vein insertion. This catheter is indicated for > 30 days long-term placement.

Source page: https://510kreport.com/device/K110936
Methodology: https://510kreport.com/methodology