FDA.reportPublic FDA data

V-Sono Intracardiac Echo Manipulator

Primary DI
M58800100246910
Brand
V-Sono Intracardiac Echo Manipulator
Company
Stereotaxis, Inc.
Model
1
Catalog number
001-002469-1
Device description
Vdrive with V-Sono is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium
Published
2016-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter
DXXSystem, Catheter Control, Steerable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
DXXSystem, Catheter Control, SteerableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122659000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122659000VDRIVE W/V-SONOStereotaxis, Inc.2013-07-26DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M58800100246910PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system workstationA mains electricity (AC-powered) device designed as a control unit to percutaneously navigate (orientate and steer) a cardiac mapping system catheter, or its associated guidewire, in the desired direction to the designated target site (e.g., coronary vasculature). It uses dedicated software and may employ various technologies (often magnetic fields); it is typically used in the electrophysiology (EP) laboratory.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
13146786100info@stereotaxis.com

Regulatory Flags#

DUNS number
024942265
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M58800100620010Niobe MNS OmegaES Omega001-006200-12026-04-23
M58800101400010GenesisX100101400012026-01-09
M588001004115110Cardiodrive SystemII001-004115-112022-06-06
M588001004115120Cardiodrive SystemII001-004115-122022-06-06
M58800101100010Genesis (RMNS) 1.1001-011000-12020-08-20
M58800101100030Genesis MNS with Model-S1.1 Model-S001-011000-32020-08-20
M588020004500210Navigant4.6.4020-004500-212016-08-01
M588020004500220Navigant4.6.5020-004500-222016-08-01
M588020004500260Navigant5.0.2020-004500-262016-10-27
M58800100701020OdysseyQuad HD001-007010-22016-08-01
M58800100111411Hemostasis AdapterIV-100100111412021-12-14
M58802000780030Cinema MAS & MMSDMS-100020-007800-32016-08-01
M58800100175110QuikCAS Cardiodrive Sterile Components1001-001751-12016-05-02
M5880010017711QuikCAS Hemostasis Adapter1001-001771-12016-08-01
M5880010017712Cardiodrive Hemostasis Adapter - SJ1001-001771-22016-08-01
M58800100230710Vdrive SystemSingle Arm001-002307-12016-08-01
M58800100230720Vdrive SystemDuo001-002307-22016-08-01
M58800100242210V-CAS Catheter Advancement System1001-002422-12016-05-02
M58800100245210V-Loop Variable Loop Catheter Manipulator1001-002452-12016-05-02
M58800100411590Cardiodrive SystemII001-004115-92016-08-01

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Primary DI, Brand, Company table
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