Pristine Hemodialysis Catheter— 510(k) K182443

Name: FDA 510(k) clearance K182443
Creator: U.S. Food and Drug Administration
Published: 2019-05-31

Substantially Equivalent

Pristine Access Technologies , Ltd.

FDA 510(k) clearance K182443 for Pristine Hemodialysis Catheter, Substantially Equivalent on 2019-05-31. Applicant: Pristine Access Technologies , Ltd.. Device class: 2.

Clearance details

Applicant: Pristine Access Technologies , Ltd.
Product code: Code MSD
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 2018-09-07
Decision date: 2019-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel-Aviv, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code MSD

view all

K241581 — Hemodialysis Catheter2025-05-16
K210461 — End Cap2021-09-14
K203575 — GlidePath Retro Long-Term Hemodialysis Catheter2021-07-01
K211410 — GlidePath 13F Long-Term Hemodialysis Catheter2021-06-04
K203767 — Pristine Long-Term Hemodialysis Catheter2021-04-02

Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.