Cleared Traditional

K081021 - KINETIX GUIDEWIRE

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

K081021 · Boston Scientific Corp · Cardiovascular device
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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

Submission Details

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.

Device Classification

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 488
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K081021.
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RUNTHROUGH NS EXTENSION WIRE
K080563 · Terumo Medical Corp. · Mar 2008