Hi-Torque Command 18 Guide Wire— 510(k) K152404

Substantially Equivalent

Abbott Vascular

FDA 510(k) clearance K152404 for Hi-Torque Command 18 Guide Wire, Substantially Equivalent on 2015-09-21. Applicant: Abbott Vascular.

Clearance details

Applicant: Abbott Vascular
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2015-08-25
Decision date: 2015-09-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.