Cardiodrive Hemostasis Adapter - SJ 001-001771-2

GUDID M5880010017712

The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.

Stereotaxis, Inc.

Cardiac mapping system workstation
Primary Device IDM5880010017712
NIH Device Record Keyc4938256-d743-4060-8928-0ce764bf5737
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardiodrive Hemostasis Adapter - SJ
Version Model Number1
Catalog Number001-001771-2
Company DUNS024942265
Company NameStereotaxis, Inc.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM5880010017712 [Primary]
HIBCCM58800100177120 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWire, Guide, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-17
Device Publish Date2016-08-01

Devices Manufactured by Stereotaxis, Inc.

M58800100175110 - QuikCAS Cardiodrive Sterile Components2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
M5880010017711 - QuikCAS Hemostasis Adapter2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
M5880010017712 - Cardiodrive Hemostasis Adapter - SJ2024-07-17The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
M5880010017712 - Cardiodrive Hemostasis Adapter - SJ2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
M58800100230710 - Vdrive System2024-07-17 "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE
M58800100230720 - Vdrive System2024-07-17 "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE
M58800100242210 - V-CAS Catheter Advancement System2024-07-17 The Vdrive with V-CAS Disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible m
M58800100245210 - V-Loop Variable Loop Catheter Manipulator2024-07-17 The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loo
M58800100246910 - V-Sono Intracardiac Echo Manipulator2024-07-17 Vdrive with V-Sono is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection
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