Coda LP Balloon Catheter— 510(k) K150970

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K150970 for Coda LP Balloon Catheter, Substantially Equivalent on 2015-05-12. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2015-04-13
Decision date: 2015-05-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, IN, 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.