Cleared Traditional

K021363 - ENDOVASCULAR GUIDE WIRE

K021363 is an FDA 510(k) clearance for ENDOVASCULAR GUIDE WIRE, manufactured by Stereotaxis, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K021363 · Stereotaxis, Inc. · Cardiovascular device
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Nov 2002
Decision
211d
Days
Class 2
Risk

K021363 is an FDA 510(k) clearance for the 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 November 27, 2002 after a review of 211 days - an extended review cycle.

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 Stereotaxis, Inc. devices

FDA 510(k) Submission Details - K021363

510(k) Number K021363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2002
Decision Date November 27, 2002
Days to Decision 211 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
86d slower than avg
Panel avg: 125d · This submission: 211d
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 703
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K021363.
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
K030617 · Boston Scientific Scimed, Inc. · May 2003
STEERABLE GUIDEWIRE
K022813 · Lake Region Mfg., Inc. · Feb 2003
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
K030019 · Guidant Corp. · Jan 2003
HI-TORQUE WHISPER LS
K023300 · Guidant Corp. · Oct 2002
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
K022357 · Boston Scientific, Target · Oct 2002
ILT ADVANCING MECHANISM, MODEL A115AMI
K021638 · Intra Luminal Therapeutics, Inc. · Jul 2002