# K182443: Pristine Hemodialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Pristine Access Technologies, Ltd.
- Decided: May 31, 2019 after 266 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: 4 generations back to K010399 (2001). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111372: Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual Lumen Catheter, Palindrome (TM)..., Covidien (2011) Summary page 4.

## Most influential descendants
- K203767: Pristine Long-Term Hemodialysis Catheter (2021), 1 descendant of its own
- K241581: Hemodialysis Catheter (2025), 0 descendants of its own

## Indications for use
The Pristine™ Hemodialysis Catheter is indicated for acute and chronic hemodialysis, apheresis and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40cm implant length are indicated for femoral placement.

Source page: https://510kreport.com/device/K182443
Methodology: https://510kreport.com/methodology