FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER— 510(k) K090509

Substantially Equivalent

Abbott Vascular-Vascular Solutions

FDA 510(k) clearance K090509 for FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER, Substantially Equivalent on 2009-03-20. Applicant: Abbott Vascular-Vascular Solutions.

Clearance details

Applicant: Abbott Vascular-Vascular Solutions
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2009-02-26
Decision date: 2009-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Clara, 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.