# K042016: Datascope Proguide Chronic Dialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: Sep 23, 2004 after 58 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972207 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994105: Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40, Medical Components, Inc. (2001) Summary page 1.

## Most influential descendants
- K090148: Proguide Chronic Dialysis Catheter (2009), 0 descendants of its own

## Indications for use
The Datascope Chronic Dialysis catheter is indicated for use in attaining long-term access for hemodialysis and apheresis. It may be implanted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein as required.

Source page: https://510kreport.com/device/K042016
Methodology: https://510kreport.com/methodology