510(k) K261631— Amplatzer TorqVue Exchange System

Substantially Equivalent

Abbott Medical

Clearance details

Applicant: Abbott Medical
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2026-05-18
Decision date: 2026-06-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint Paul, MN, US

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.