EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE— 510(k) K033542

Name: FDA 510(k) clearance K033542
Creator: U.S. Food and Drug Administration
Published: 2003-12-05

Substantially Equivalent

Galt Medical Corp.

FDA 510(k) clearance K033542 for EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE, Substantially Equivalent on 2003-12-05. Applicant: Galt Medical Corp.. Device class: 2.

Clearance details

Applicant: Galt Medical Corp.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2003-11-10
Decision date: 2003-12-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Garland, TX, 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.