Pristine Long-Term Hemodialysis Catheter— 510(k) K203767

Unknown

C B Bard, Inc.

FDA 510(k) clearance K203767 for Pristine Long-Term Hemodialysis Catheter, Unknown on 2021-04-02. Applicant: C B Bard, Inc..

Clearance details

Applicant: C B Bard, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2020-12-23
Decision date: 2021-04-02
Decision: Unknown
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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.