AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120— 510(k) K093476

Substantially Equivalent

Aga Medical Corp.

FDA 510(k) clearance K093476 for AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120, Substantially Equivalent on 2010-02-05. Applicant: Aga Medical Corp..

Clearance details

Applicant: Aga Medical Corp.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2009-11-09
Decision date: 2010-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
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.