Cleared Traditional

K173235 - Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173235 · Scientia Vascular, LLC · Cardiovascular device
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Jan 2018
Decision
109d
Days
Class 2
Risk

K173235 is an FDA 510(k) clearance for the Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, S.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Scientia Vascular, LLC (West Valley City, US). The FDA issued a Cleared decision on January 22, 2018 after a review of 109 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 Scientia Vascular, LLC devices

Submission Details

510(k) Number K173235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2017
Decision Date January 22, 2018
Days to Decision 109 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 125d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 762
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