Cleared Special

K051374 - CARDIODRIVE CATHETER ADVANCEMENT SYSTEM

K051374 is an FDA 510(k) clearance for CARDIODRIVE CATHETER ADVANCEMENT SYSTEM, manufactured by Stereotaxis, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 28-day FDA review.

K051374 · Stereotaxis, Inc. · Cardiovascular device
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Jun 2005
Decision
28d
Days
Class 2
Risk

K051374 is an FDA 510(k) clearance for the CARDIODRIVE CATHETER ADVANCEMENT SYSTEM. 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 June 23, 2005 after a review of 28 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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

FDA 510(k) Submission Details - K051374

510(k) Number K051374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2005
Decision Date June 23, 2005
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K051374.
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
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K050915 · Intra Luminal Therapeutics, Inc. · Jun 2005
CANALIZER HYDROPHILIC GUIDE WIRE
K050873 · Medical Device Technologies, Inc. · May 2005