Cleared Traditional

K160594 - MRWire Guide Wire

K160594 is the FDA 510(k) clearance for MRWire Guide Wire by Nano4imaging GmbH. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K160594 · Nano4imaging GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
266d
Days
Class 2
Risk

K160594 is an FDA 510(k) clearance for the MRWire Guide Wire. 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 22, 2016 after a review of 266 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Nano4imaging GmbH devices

Submission Details

510(k) Number K160594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2016
Decision Date November 22, 2016
Days to Decision 266 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 125d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - DQX Wire, Guide, Catheter

All 502
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K160594.
ASAHI PTCA Guide Wire ASAHI SUOH 03
K162842 · Asahi Intecc Co., Ltd. · Jan 2017
Spectre guidewire
K163444 · Vascular Solutions, Inc. · Jan 2017
Endura guidewire
K161702 · Vascular Solutions, Inc. · Dec 2016
ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
K161584 · Asahi Intecc Co., Ltd. · Oct 2016
Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip
K161887 · Volcano Corporation · Sep 2016
ASAHI Fielder XT-A, ASAHI Fielder XT-R
K153106 · Asahi Intecc Co., Ltd. · Jun 2016