# K090148: Proguide Chronic Dialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Apr 13, 2009 after 82 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: 3 generations back to K972207 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042016: Datascope Proguide Chronic Dialysis Catheter, Datascope Corp. (2004) Summary page 1.
- K040402: Angiodynamics, Inc. More-Flow Hemodialysis Catheter and Procedure Kit, AngioDynamics, Inc. (2004) Summary page 1.

## Recalls of this device
- Feb 13, 2026 · Class I · Z-1576-2026: 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 ProGuide Chronic Dialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be implanted percutaneously and is primarily placed in the internal jugular or subclavian vein of an adult patient. Catheters greater than 40 cm are intended for femoral vein insertion.

Source page: https://510kreport.com/device/K090148
Methodology: https://510kreport.com/methodology