# K100169: Duraspan Hemodialysis Long-Term Catheter

- Pathway: 510(k) (Special)
- Applicant: R4 Vascular, Inc.
- Decided: Feb 18, 2010 after 29 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Duraspan Long-Term Hemodialysis Catheter (Ultra): named in the summary without a submission number

## Recalls of this device
- May 3, 2011 · Not classified · Z-2412-2011: r4 Vascular, Inc. is conducting a voluntary recall of specific lots of Duraspan Dialysis Catheters. Duraspan catheters are 15.5 Fr dual lumen chronic hemodialysis catheters. Over a six month period, s

## Indications for use
The r4 Duraspan TM and the Duraspan TM Ultra long-term dialysis catheter is indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of-the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.

Source page: https://510kreport.com/device/K100169
Methodology: https://510kreport.com/methodology