K063871

Substantially Equivalent

D-STAT HANDLE, MODEL 8500-053

Applicant: Vascular Solutions, Inc.
Product code: DXC
Advisory panel: Cardiovascular
Date received: 2006-12-29
Decision date: 2007-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.