Cleared Traditional

K081021 - KINETIX GUIDEWIRE, PLUS GUIDEWIRE

K081021 is an FDA 510(k) clearance for KINETIX GUIDEWIRE, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K081021 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
120d
Days
Class 2
Risk

K081021 is an FDA 510(k) clearance for the KINETIX GUIDEWIRE, PLUS GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on August 8, 2008 after a review of 120 days - within the typical 510(k) review window.

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 Corp devices

FDA 510(k) Submission Details - K081021

510(k) Number K081021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2008
Decision Date August 08, 2008
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
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 675
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K081021.
ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
K083146 · Asahi Intecc Co., Ltd. · Nov 2008
ROLL-X GUIDEWIRE
K082304 · St Jude Medical · Aug 2008
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
K080637 · Stereotaxis, Inc. · Aug 2008
APPROACH CTO WIRE GUIDE
K081337 · Cook Incorporated · Aug 2008
TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
K080863 · MicroVention, Inc. · Apr 2008
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
K072460 · Abbott Vascular, Inc. · Apr 2008