MR Wire Guide Wire Straight, MR Wire Guide Wire Angled— 510(k) K173423

Name: FDA 510(k) clearance K173423
Creator: U.S. Food and Drug Administration
Published: 2017-11-17

Substantially Equivalent

Nano4imaging GmbH

FDA 510(k) clearance K173423 for MR Wire Guide Wire Straight, MR Wire Guide Wire Angled, Substantially Equivalent on 2017-11-17. Applicant: Nano4imaging GmbH. Device class: 2.

Clearance details

Applicant: Nano4imaging GmbH
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2017-11-01
Decision date: 2017-11-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Aachen, DE

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.