510(k) K182443— Pristine Hemodialysis Catheter

Substantially Equivalent

Pristine Access Technologies , Ltd.

Clearance details

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

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.