AMPLATZER TorqVue 45x45 Delivery Sheath— 510(k) K163000

Substantially Equivalent

Aga Medical COrporation (Wholly Owned by St. Jude Medical CO

FDA 510(k) clearance K163000 for AMPLATZER TorqVue 45x45 Delivery Sheath, Substantially Equivalent on 2016-12-23. Applicant: Aga Medical COrporation (Wholly Owned by St. Jude Medical CO.

Clearance details

Applicant: Aga Medical COrporation (Wholly Owned by St. Jude Medical CO
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2016-10-28
Decision date: 2016-12-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, 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.