Cleared Traditional

K200120 - LiteSaber Wire Torque Assist Device

K200120 is an FDA 510(k) clearance for LiteSaber Wire Torque Assist Device, manufactured by Vesatek, LLC. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K200120 · Vesatek, LLC · Cardiovascular device
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May 2020
Decision
107d
Days
Class 2
Risk

K200120 is an FDA 510(k) clearance for the LiteSaber Wire Torque Assist Device. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Vesatek, LLC (Irvine, US). The FDA issued a Cleared decision on May 7, 2020 after a review of 107 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 Vesatek, LLC devices

FDA 510(k) Submission Details - K200120

510(k) Number K200120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2020
Decision Date May 07, 2020
Days to Decision 107 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
18d faster than avg
Panel avg: 125d · This submission: 107d
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 685
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K200120.
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