Go2Wire Guide Wire

FDA 510(k) K193571 · Merit Medical System, Inc.

Substantially Equivalent

510(k) numberK193571

Submission

Device name
Go2Wire Guide Wire
Applicant
Merit Medical System, Inc.
Galway, IE
Received
December 23, 2019
Decision date
April 8, 2020
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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Questions and answers

When was Go2Wire Guide Wire cleared by the FDA?

Go2Wire Guide Wire (K193571) received a 510(k) decision of Substantially Equivalent on April 8, 2020, 107 days after the submission was received.

What is the product code of K193571?

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