Traxcess .007 Mini Guidewire— 510(k) K161803

Name: FDA 510(k) clearance K161803
Creator: U.S. Food and Drug Administration
Published: 2016-09-30

Substantially Equivalent

MicroVention, Inc.

FDA 510(k) clearance K161803 for Traxcess .007 Mini Guidewire, Substantially Equivalent on 2016-09-30. Applicant: MicroVention, Inc.. Device class: 2.

Clearance details

Applicant: MicroVention, Inc.
Product code: Code MOF
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2016-06-30
Decision date: 2016-09-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Tistin, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MOF

product code MOF

Death: 6
Injury: 137
Total: 143

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 →

Recalls naming K161803

K-number listed on FDA's recall record

Z-3103-2017 — MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.Class II·Terminated·Microvention, Inc.·20170807

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161803.

Data sourced from openFDA. This site is unofficial and independent of the FDA.