Cleared Special

K042854 - STEREOTAXIS ENDOVASCULAR GUIDE WIRE

K042854 is the FDA 510(k) clearance for STEREOTAXIS ENDOVASCULAR GUIDE WIRE by Stereotaxis, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Special 510(k) pathway after a 116-day FDA review.

K042854 · Stereotaxis, Inc. · Cardiovascular device
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Feb 2005
Decision
116d
Days
Class 2
Risk

K042854 is an FDA 510(k) clearance for the STEREOTAXIS ENDOVASCULAR GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on February 8, 2005 after a review of 116 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stereotaxis, Inc. devices

Submission Details

510(k) Number K042854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2004
Decision Date February 08, 2005
Days to Decision 116 days
Submission Type Special
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
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Modification to existing cleared device.

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 520
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K042854.
CANALIZER HYDROPHILIC GUIDE WIRE
K050873 · Medical Device Technologies, Inc. · May 2005
GALEO FOCUS GUIDE WIRE
K042373 · Biotronik, Inc. · Mar 2005
MODIFICATION TO ENDOVASCULAR GUIDE WIRE
K043457 · Stereotaxis, Inc. · Feb 2005
ASAHI PTCA GUIDE WIRE, J SHAPE SERIES
K043422 · Asahi Intecc Co., Ltd. · Jan 2005
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
K040592 · Cordis Corp. · Dec 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
K042611 · Cook, Inc. · Nov 2004