S-Wire Guidewire System

FDA 510(k) K153397 · Concert Medical, LLC

Substantially Equivalent

510(k) numberK153397

Submission

Device name
S-Wire Guidewire System
Applicant
Concert Medical, LLC
Norwell, MA, US
Received
November 24, 2015
Decision date
August 18, 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.

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Questions and answers

When was S-Wire Guidewire System cleared by the FDA?

S-Wire Guidewire System (K153397) received a 510(k) decision of Substantially Equivalent on August 18, 2016, 268 days after the submission was received.

What is the product code of K153397?

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