Cleared Traditional

K152231 - Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire

K152231 is an FDA 510(k) clearance for Hornet 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 189-day FDA review.

K152231 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
189d
Days
Class 2
Risk

K152231 is an FDA 510(k) clearance for the Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 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 February 12, 2016 after a review of 189 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 - K152231

510(k) Number K152231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2015
Decision Date February 12, 2016
Days to Decision 189 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
64d slower than avg
Panel avg: 125d · This submission: 189d
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 K152231.
ASAHI Fielder XT-A, ASAHI Fielder XT-R
K153106 · Asahi Intecc Co., Ltd. · Jun 2016
Arrow Quickflash Arterial Catheterization Device
K160018 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Jun 2016
ASAHI Astato XS 40
K153443 · Asahi Intecc Co., Ltd. · Feb 2016
OptoWire Deux
K152991 · Opsens · Feb 2016
PW Guidewires
K152497 · Tatara Vascular, LLC · Jan 2016
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
K151840 · Boston Scientific Corporation · Dec 2015