DISTAL ACCESS TORQUE DEVICE— 510(k) K141054

Name: FDA 510(k) clearance K141054
Creator: U.S. Food and Drug Administration
Published: 2014-12-10

Substantially Equivalent

Distal Access, LLC

FDA 510(k) clearance K141054 for DISTAL ACCESS TORQUE DEVICE, Substantially Equivalent on 2014-12-10. Applicant: Distal Access, LLC. Device class: 2.

Clearance details

Applicant: Distal Access, LLC
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2014-04-18
Decision date: 2014-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park City, UT, US

Download summary PDF View on FDA.gov ↗

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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.