Cleared Traditional

K153397 - S-Wire Guidewire System

K153397 is an FDA 510(k) clearance for S-Wire Guidewire System, manufactured by Concert Medical, LLC. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K153397 · Concert Medical, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
268d
Days
Class 2
Risk

K153397 is an FDA 510(k) clearance for the S-Wire Guidewire System. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Concert Medical, LLC (Norwell, US). The FDA issued a Cleared decision on August 18, 2016 after a review of 268 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 Concert Medical, LLC devices

FDA 510(k) Submission Details - K153397

510(k) Number K153397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2015
Decision Date August 18, 2016
Days to Decision 268 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
143d slower than avg
Panel avg: 125d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - DQX Wire, Guide, Catheter

All 593
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K153397.
Endura guidewire
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K161887 · Volcano Corporation · Sep 2016
ASAHI Fielder XT-A, ASAHI Fielder XT-R
K153106 · Asahi Intecc Co., Ltd. · Jun 2016
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K153443 · Asahi Intecc Co., Ltd. · Feb 2016
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
K152231 · Boston Scientific Corporation · Feb 2016