THE AMPLANTZ GOOSE NECK MICROSNARE— 510(k) K970668

Substantially Equivalent

Microvena Corp.

FDA 510(k) clearance K970668 for THE AMPLANTZ GOOSE NECK MICROSNARE, Substantially Equivalent on 1998-06-10. Applicant: Microvena Corp..

Clearance details

Applicant: Microvena Corp.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 1997-02-24
Decision date: 1998-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Bear Lake, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.