Cleared Traditional

K100093 - VSI TORQUE DEVICE

K100093 is an FDA 510(k) clearance for VSI TORQUE DEVICE, manufactured by Vascular Solutions, Inc.. 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.

K100093 · Vascular Solutions, Inc. · Cardiovascular device
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Apr 2010
Decision
107d
Days
Class 2
Risk

K100093 is an FDA 510(k) clearance for the VSI TORQUE DEVICE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 30, 2010 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 Vascular Solutions, Inc. devices

FDA 510(k) Submission Details - K100093

510(k) Number K100093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2010
Decision Date April 30, 2010
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 662
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K100093.
HI-TORQUE WINN GUIDE WIRE FAMILY
K101648 · Abbott Vascular, Inc. · Jul 2010
HASKAL TORQUE DEVICE
K100425 · Elcam Medical Acal · Jun 2010
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
K101011 · Abbott Vascular, Inc. · May 2010
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J
K100930 · Volcano Corporation · Apr 2010
ROLL-X GUIDEWIRE
K100710 · St Jude Medical · Apr 2010
GTX 12 GIDEWIRE
K100470 · Medtronic, Inc. · Apr 2010