Cleared Traditional

K140804 - VDRIVE WITH V-LOOP/ VDRIVE DUO

K140804 is an FDA 510(k) clearance for VDRIVE WITH V-LOOP/ VDRIVE DUO, manufactured by Stereotaxis, Inc.. The device is a Class 2 Cardiovascular device with product code DXX cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K140804 · Stereotaxis, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
156d
Days
Class 2
Risk

K140804 is an FDA 510(k) clearance for the VDRIVE WITH V-LOOP/ VDRIVE DUO. Classified as System, Catheter Control, Steerable (product code DXX), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (Fairfax, US). The FDA issued a Cleared decision on September 3, 2014 after a review of 156 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1290 - 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 - K140804

510(k) Number K140804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2014
Decision Date September 03, 2014
Days to Decision 156 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
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

DXX Device Classification - Class 2, Special Controls

Product Code DXX System, Catheter Control, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1290
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01656772 Completed Interventional Industry-sponsored

Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study

120
Patients (actual)
5
Sites
Treatment
Purpose
Open label
Masking
Condition studied Atrial Fibrillation
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Qun Sha, MD
Sponsor Stereotaxis (industry)
Started 2012-08-01 → Primary completion 2013-12-01
Primary outcome
The Primary Effectiveness Endpoint is the Successful Navigation and EGM Recording of Each Pre-specified Pulmonary Vein Per Procedure Between Both the Control and the Investigational Device Groups.
View full study on ClinicalTrials.gov

Regulatory Peers - DXX System, Catheter Control, Steerable

All 31
Devices cleared under the same product code (DXX) and FDA review panel - the closest regulatory comparables to K140804.
Magellan Robotic System, Magellan Robotic Catheter 10Fr
K143227 · Hansen Medical, Inc. · Jul 2015
Vdrive system, Vdrive Duo, Vdrive with V-Sono
K150312 · Stereotaxis, Inc. · Jun 2015
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
K141530 · Stereotaxis, Inc. · Dec 2014
MAGELLAN ROBOTIC SYSTEM
K141614 · Hansen Medical · Aug 2014
SENSEI X ROBOTIC CATHETER SYSTEM
K141822 · Hanson Medical, Inc. · Aug 2014
MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
K132369 · Hansen Medical, Inc. · Sep 2013