Cleared Traditional

K151840 - Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire

K151840 is an FDA 510(k) clearance for Fighter Guidewire, manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K151840 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
163d
Days
Class 2
Risk

K151840 is an FDA 510(k) clearance for the Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire,.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on December 16, 2015 after a review of 163 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 Boston Scientific Corporation devices

FDA 510(k) Submission Details - K151840

510(k) Number K151840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2015
Decision Date December 16, 2015
Days to Decision 163 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 125d · This submission: 163d
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 684
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K151840.
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
K152231 · Boston Scientific Corporation · Feb 2016
OptoWire Deux
K152991 · Opsens · Feb 2016
PW Guidewires
K152497 · Tatara Vascular, LLC · Jan 2016
R350 guidewire
K151234 · Vascular Solutions, Inc. · Nov 2015
Radifocus Glidewire
K152740 · Ashitaka Factory of Terumo Corp. · Nov 2015
HI-TORQUE BALANCE
K152709 · Abbott Vascular · Oct 2015