NC TREK OTW CORONARY DILATATION CATHETER— 510(k) K113464

Substantially Equivalent

Abbott Vascular

FDA 510(k) clearance K113464 for NC TREK OTW CORONARY DILATATION CATHETER, Substantially Equivalent on 2012-03-06. Applicant: Abbott Vascular.

Clearance details

Applicant: Abbott Vascular
Product code: Code LOX
Advisory panel: Cardiovascular
Date received: 2011-11-22
Decision date: 2012-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LOX

product code LOX

Death: 190
Injury: 1,498
Malfunction: 9,670
Total: 11,358

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.