TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER— 510(k) K121222

Substantially Equivalent

Abbott Vascular

FDA 510(k) clearance K121222 for TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER, Substantially Equivalent on 2012-06-22. Applicant: Abbott Vascular.

Clearance details

Applicant: Abbott Vascular
Product code: Code LOX
Advisory panel: Cardiovascular
Date received: 2012-04-23
Decision date: 2012-06-22
Decision: Substantially Equivalent
Clearance type: Special
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.