STEREOTAXIS, INC.

Address:710 N. Tucker Blvd., Suite 110,Saint Louis,MO,63101,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Wire, Guide, Catheter (DQX) (10) System, Catheter Control, Steerable (DXX) (5)

Premarket Exempt

No Yes

Clear

Hemostasis Adapter - M58800100111411 Catalog Number : 0010011141

Device Description : Hemostasis Adapter IV Spares, Box, Device Count(5)

Device Class : 2

Duns Number: 024942265

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

QuikCAS Cardiodrive Sterile Components - M58800100175110 Catalog Number : 001-001751-1

Device Description : The Stereotaxis Cardiodrive is intended for automatically advancing and retracti

Device Class : 2

Duns Number: 024942265

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

QuikCAS Hemostasis Adapter - M5880010017711 Catalog Number : 001-001771-1

Device Description : The Stereotaxis Cardiodrive is intended for automatically advancing and retracti

Device Class :

Duns Number: 024942265

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Cardiodrive Hemostasis Adapter - SJ - M5880010017712 Catalog Number : 001-001771-2

Device Description : The Stereotaxis Cardiodrive is intended for automatically advancing and retracti

Device Class :

Duns Number: 024942265

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Vdrive System - M58800100230710 Catalog Number : 001-002307-1

Device Description : "The Vdrive® system is intended to stabilize, navigate and remotely control: • C

Device Class : 2

Duns Number: 024942265

Premarket Exempt : No

Product Code : DXX, DQX

Prescription Use : Yes

Device Count : 1

Vdrive System - M58800100230720 Catalog Number : 001-002307-2

Device Description : "The Vdrive® system is intended to stabilize, navigate and remotely control: • C

Device Class : 2

Duns Number: 024942265

Premarket Exempt : No

Product Code : DXX, DQX

Prescription Use : Yes

Device Count : 1

V-CAS Catheter Advancement System - M58800100242210 Catalog Number : 001-002422-1

Device Description : The Vdrive with V-CAS Disposable is indicated for remotely controlling the advan

Device Class : 2

Duns Number: 024942265

Premarket Exempt : No

Product Code : DXX, DQX

Prescription Use : Yes

Device Count : 1

V-Loop Variable Loop Catheter Manipulator - M58800100245210 Catalog Number : 001-002452-1

Device Description : The Vdrive with V-Loop disposable is indicated to remotely control the advanceme

Device Class : 2

Duns Number: 024942265

Premarket Exempt : No

Product Code : DXX, DQX

Prescription Use : Yes

Device Count : 1

V-Sono Intracardiac Echo Manipulator - M58800100246910 Catalog Number : 001-002469-1

Device Description : Vdrive with V-Sono is indicated for remotely controlling the advancement, retrac

Device Class : 2

Duns Number: 024942265

Premarket Exempt : No

Product Code : DXX, DQX

Prescription Use : Yes

Device Count : 1

Cardiodrive System - M588001004115110 Catalog Number : 001-004115-11

Device Description : The Stereotaxis Cardiodrive is intended for automatically advancing and retracti

Device Class : 2

Duns Number: 024942265

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

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