510(k) K901502— AMPLATZ GOOSE-NECK SNARE

Substantially Equivalent

Microvena Corp.

Clearance details

Applicant: Microvena Corp.
Product code: Code DXE
Advisory panel: Cardiovascular
Date received: 1990-03-29
Decision date: 1990-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Findley, MN, US

Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

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.