ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM— 510(k) K141218

Name: FDA 510(k) clearance K141218
Creator: U.S. Food and Drug Administration
Published: 2014-12-18

Substantially Equivalent

Vadiswire Corporation

FDA 510(k) clearance K141218 for ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM, Substantially Equivalent on 2014-12-18. Applicant: Vadiswire Corporation. Device class: 2.

Clearance details

Applicant: Vadiswire Corporation
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2014-05-12
Decision date: 2014-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kirkland, WA, US

Download summary PDF View on FDA.gov ↗

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K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

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.