# K151967: Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Apr 4, 2016 after 263 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: 9 generations back to K981994 (1998). 17 ancestors in all.
No later device cites it as a predicate yet.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141363: Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis Catheter, Merit Medical Systems, Inc. (2014) Summary page 4.

## Recalls of this device
- Feb 13, 2026 · Class I · Z-1575-2026: 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

## Indications for use
The Merit Centros and CentrosFLO Long-Term Hemodialysis Catheter are 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. This catheter is indicated for > 30 days, (long-term) placement.

Source page: https://510kreport.com/device/K151967
Methodology: https://510kreport.com/methodology