# K131260: Nmi Dialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Navilyst Medical, Inc.
- Decided: Feb 14, 2014 after 288 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001901 (2000). 58 ancestors in all.
No later device cites it as a predicate yet.
4 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121089: Nmi Picc Iii, Navilyst Medical, Inc. (2012) Summary page 1.
- K101843: Duramax Chronic Hemodialysis Catheter and Procedure Kit, AngioDynamics, Inc. (2010)

## Recalls of this device
- Feb 13, 2026 · Class I · Z-1579-2026: 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired cathe
- Mar 18, 2024 · Class II · Z-1774-2024: 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 NML Dialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis in adults. Catheters greater than 40 cm are intended for femoral vein insertion.

Source page: https://510kreport.com/device/K131260
Methodology: https://510kreport.com/methodology