Cleared Special

K173423 - MR Wire Guide Wire Straight, MR Wire Guide Wire Angled

K173423 is an FDA 510(k) clearance for MR Wire Guide Wire Straight, manufactured by Nano4imaging GmbH. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 16-day FDA review.

K173423 · Nano4imaging GmbH · Cardiovascular device
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Nov 2017
Decision
16d
Days
Class 2
Risk

K173423 is an FDA 510(k) clearance for the MR Wire Guide Wire Straight, MR Wire Guide Wire Angled. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Nano4imaging GmbH (Aachen, DE). The FDA issued a Cleared decision on November 17, 2017 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nano4imaging GmbH devices

FDA 510(k) Submission Details - K173423

510(k) Number K173423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2017
Decision Date November 17, 2017
Days to Decision 16 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

G & L Scientific
Judith Harrington

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQX Wire, Guide, Catheter

All 685
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