DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER— 510(k) K042016

Substantially Equivalent

Datascope Corp.

FDA 510(k) clearance K042016 for DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER, Substantially Equivalent on 2004-09-23. Applicant: Datascope Corp..

Clearance details

Applicant: Datascope Corp.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2004-07-27
Decision date: 2004-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manwah, NJ, 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.