ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY— 510(k) K060745

Substantially Equivalent

Asahi Intecc Co., Ltd.

FDA 510(k) clearance K060745 for ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY, Substantially Equivalent on 2006-06-23. Applicant: Asahi Intecc Co., Ltd..

Clearance details

Applicant: Asahi Intecc Co., Ltd.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2006-03-20
Decision date: 2006-06-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Newport Beach, CA, 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.