BLADDERMANAGER PCI 5000 MODEL 1002— 510(k) K982568

Substantially Equivalent

Diagnostic Ultrasound Corp.

FDA 510(k) clearance K982568 for BLADDERMANAGER PCI 5000 MODEL 1002, Substantially Equivalent on 1999-01-25. Applicant: Diagnostic Ultrasound Corp..

Clearance details

Applicant: Diagnostic Ultrasound Corp.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1998-07-23
Decision date: 1999-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.