Cleared Special

K133396 - VDRIVE WITH V-SONO (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K133396 · Stereotaxis, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
92d
Days
Class 2
Risk

K133396 is an FDA 510(k) clearance for the VDRIVE WITH V-SONO. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 6, 2014 after a review of 92 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 K133396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2013
Decision Date February 06, 2014
Days to Decision 92 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
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 762
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K133396.
FMD Peripheral Guide Wire F-14 Flex 6
K260544 · FMD Co., Ltd. · Mar 2026
Enroute 0.014'' Transcarotid Guidewire
K253746 · Lake Region Medical · Mar 2026
EmeryGlide™ (EG18008901)
K253262 · Nano4imaging GmbH · Mar 2026
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
K253847 · Merit Medical Ireland, Ltd. · Jan 2026
InQwire Super Stiff Guide Wire (IQSS32180J3)
K251385 · Merit Medical Ireland, Ltd. · Jan 2026
Solo Pace Fusion System (SOLOFUSE1)
K252674 · Solo Pace, Inc. · Jan 2026