# K982333: Modification to Uldall Double Lumen Hemodialysis Catheter Set and Tray

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Feb 12, 1999 after 225 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: 1 generation back to K871749 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913468: Uldall Double Lumen Hemodialysis Catheter Set/Tray, Cook, Inc. (1994). Our OCR of the scanned summary read K923468, FDA’s number for Micro Eia for Opiate Metabolites (Microdiagnostics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Uldall Double Lumen Hemodialysis Catheter”.
- K871749: Adult Perm-Cath 40CM., Quinton, Inc. (1987) Summary page 2.

## Indications for use
The Uldall Double Lumen Hemodialysis Catheter is designed for short or long-term hemodialysis access in the presence of renal failure. Percutaneously placed double lumen catheter is intended for blood infusion and withdrawal. This device and components of the tray are supplied sterile and intended for single-use only.

Source page: https://510kreport.com/device/K982333
Methodology: https://510kreport.com/methodology