MRWire Guide Wire

Q: When was MRWire Guide Wire cleared by the FDA?

MRWire Guide Wire (K160594) received a 510(k) decision of Substantially Equivalent on November 22, 2016, 266 days after the submission was received.

Q: What is the product code of K160594?

The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.

FDA 510(k) K160594 · Nano4imaging GmbH

Substantially Equivalent

510(k) numberK160594

Submission

Device name: MRWire Guide Wire
Applicant: Nano4imaging GmbH
Aachen, DE
Received: March 1, 2016
Decision date: November 22, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DQX – Wire, Guide, Catheter
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1330
Specialty: Cardiovascular

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More from Solo Pace, Inc.

510(k)	Device	Decision
K253262	EmeryGlide (EG18008901)DQX · Special	03/06/2026SE
K173423	MR Wire Guide Wire Straight, MR Wire Guide Wire AngledDQX · Special	11/17/2017SE

Questions and answers

When was MRWire Guide Wire cleared by the FDA?

MRWire Guide Wire (K160594) received a 510(k) decision of Substantially Equivalent on November 22, 2016, 266 days after the submission was received.

What is the product code of K160594?

The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.