AMPLATZER SIZING BALLOON II— 510(k) K053440

Substantially Equivalent

Aga Medical Corp.

FDA 510(k) clearance K053440 for AMPLATZER SIZING BALLOON II, Substantially Equivalent on 2005-12-30. Applicant: Aga Medical Corp..

Clearance details

Applicant: Aga Medical Corp.
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2005-12-09
Decision date: 2005-12-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.