No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00816280022096 | 160-00981 | 160-00981 | DXX | System, Catheter Control, Steerable | CorPath 200 Control Console Drape | ||
2 | 00816280022034 | 160-00050 | 160-00050 | DXX | System, Catheter Control, Steerable | 2 | CorPath 200 Robotic Drive | |
3 | 00816280022072 | 160-00876 | 160-00876 | DXX | System, Catheter Control, Steerable | CorPath 200 POGO Pin Caps | ||
4 | 00816280023116 | 311 | 311 | DXX | System, Catheter Control, Steerable | CorPath GRX Drape, Control Console | ||
5 | 00816280023017 | 301 | 301 | DXX | System, Catheter Control, Steerable | 2 | CorPath GRX Control Console | |
6 | 00816280022133 | 160-00828 | 160-00828 | DXX | System, Catheter Control, Steerable | CorPath 200 Robotic Drive Drape | ||
7 | 00816280021013 | 101 | 101 | IWX | Barrier, Control Panel, X-Ray, Movable | 1 | CorPath Interventional Cockpit | |
8 | 00816280023055 | 305 | 305 | DXX | System, Catheter Control, Steerable | CorPath GRX Cassette | ||
9 | 00816280022010 | 160-00043 | 160-00043 | DXX | System, Catheter Control, Steerable | 2 | CorPath 200 Control Console | |
10 | 00816280021068 | 106 | 106 | OUG | Medical Device Data System | 1 | CorPath Imaging System | |
11 | 00816280021051 | 105 | 105 | OUG | Medical Device Data System | 1 | CorPath Imaging System | |
12 | 00816280023123 | 312 | 312 | DXX | System, Catheter Control, Steerable | 2 | CorPath GRX Extended Reach Arm | |
13 | 00816280023024 | 302 | 302 | DXX | System, Catheter Control, Steerable | 2 | CorPath GRX Extended Reach Arm | |
14 | 00816280023093 | 309 | 309 | DXX | System, Catheter Control, Steerable | CorPath GRX Drape, Robotic Drive and Arm | ||
15 | 00816280023079 | 307 | 307 | DXX | System, Catheter Control, Steerable | CorPath GRX Drive Gear | ||
16 | 00816280022119 | 160-00692 | 160-00692 | DXX | System, Catheter Control, Steerable | CorPath 200 Joystick Covers | ||
17 | 00816280022027 | 160-00807 | 160-00807 | DXX | System, Catheter Control, Steerable | 2 | CorPath 200 Articulated Arm | |
18 | 00816280021044 | 104 | 104 | OUG | Medical Device Data System | 1 | Powervision Imaging System | |
19 | 00816280021037 | 103 | 103 | OUG | Medical Device Data System | 1 | Powervision Imaging System | |
20 | 00816280022041 | 160-00173-NC | 160-00173-NC | DXX | System, Catheter Control, Steerable | 2 | CorPath 200 Cassette | |
21 | 00816280021020 | 102 | 102 | OUG | Medical Device Data System | 1 | Powervision Imaging System | |
22 | 00816280023031 | 303 | 303 | DXX | System, Catheter Control, Steerable | 2 | CorPath GRX Robotic Drive |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10815671020083 | MD6PK | MD6PK | Magellan Robotic System Sterile Drape | Magellan™ | HANSEN MEDICAL, INC. |
2 | 10815671020007 | 06196 | 06196 | Artisan Family Catheter Sterile Drape | Artisan® | HANSEN MEDICAL, INC. |
3 | M58800101005611 | 1 | 001-010056-1 | "The Vdrive® system is intended to stabilize, navigate and remotely control: • C "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). " | Vdrive Drape | STEREOTAXIS, INC. |
4 | M58800100701020 | Quad HD | 001-007010-2 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Odyssey | STEREOTAXIS, INC. |
5 | M58800100246910 | 1 | 001-002469-1 | Vdrive with V-Sono is indicated for remotely controlling the advancement, retrac 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 | V-Sono Intracardiac Echo Manipulator | STEREOTAXIS, INC. |
6 | M58800100245210 | 1 | 001-002452-1 | The Vdrive with V-Loop disposable is indicated to remotely control the advanceme The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loop size of compatibile loop catheters inserted across the septum into the left atrium using conventional procedures | V-Loop Variable Loop Catheter Manipulator | STEREOTAXIS, INC. |
7 | M58800100242210 | 1 | 001-002422-1 | The Vdrive with V-CAS Disposable is indicated for remotely controlling the advan The Vdrive with V-CAS Disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System | V-CAS Catheter Advancement System | STEREOTAXIS, INC. |
8 | M58800100230720 | Duo | 001-002307-2 | "The Vdrive® system is intended to stabilize, navigate and remotely control: • C "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). " | Vdrive System | STEREOTAXIS, INC. |
9 | M58800100230710 | Single Arm | 001-002307-1 | "The Vdrive® system is intended to stabilize, navigate and remotely control: • C "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). " | Vdrive System | STEREOTAXIS, INC. |
10 | 00816280023192 | 319 | 319 | CorPath GRX Cassette Duo | CORINDUS, INC. | |
11 | 00816280023123 | 312 | 312 | CorPath GRX Extended Reach Arm | CORINDUS, INC. | |
12 | 00816280023116 | 311 | 311 | CorPath GRX Drape, Control Console | CORINDUS, INC. | |
13 | 00816280023093 | 309 | 309 | CorPath GRX Drape, Robotic Drive and Arm | CORINDUS, INC. | |
14 | 00816280023079 | 307 | 307 | CorPath GRX Drive Gear | CORINDUS, INC. | |
15 | 00816280023055 | 305 | 305 | CorPath GRX Cassette | CORINDUS, INC. | |
16 | 00816280023031 | 303 | 303 | CorPath GRX Robotic Drive | CORINDUS, INC. | |
17 | 00816280023024 | 302 | 302 | CorPath GRX Extended Reach Arm | CORINDUS, INC. | |
18 | 00816280023017 | 301 | 301 | CorPath GRX Control Console | CORINDUS, INC. | |
19 | 00816280022133 | 160-00828 | 160-00828 | CorPath 200 Robotic Drive Drape | CORINDUS, INC. | |
20 | 00816280022119 | 160-00692 | 160-00692 | CorPath 200 Joystick Covers | CORINDUS, INC. | |
21 | 00816280022096 | 160-00981 | 160-00981 | CorPath 200 Control Console Drape | CORINDUS, INC. | |
22 | 00816280022072 | 160-00876 | 160-00876 | CorPath 200 POGO Pin Caps | CORINDUS, INC. | |
23 | 00816280022041 | 160-00173-NC | 160-00173-NC | CorPath 200 Cassette | CORINDUS, INC. | |
24 | 00816280022034 | 160-00050 | 160-00050 | CorPath 200 Robotic Drive | CORINDUS, INC. | |
25 | 00816280022027 | 160-00807 | 160-00807 | CorPath 200 Articulated Arm | CORINDUS, INC. | |
26 | 00816280022010 | 160-00043 | 160-00043 | CorPath 200 Control Console | CORINDUS, INC. | |
27 | 00815671020321 | MAR100 | MAR100 | Magellan Robotic System 120V | Magellan™ | HANSEN MEDICAL, INC. |
28 | 00815671020314 | MTS100 | MTS100 | Magellan Transport System | Magellan™ | HANSEN MEDICAL, INC. |
29 | 00815671020284 | 11132 | 11132 | Magellan Robotic System 120V | Magellan™ | HANSEN MEDICAL, INC. |
30 | 00815671020260 | SRS200 | SRS200 | Sensei X2 Robotic System 120V | Sensei® | HANSEN MEDICAL, INC. |
31 | 00815671020246 | 08257 | 08257 | Sensei X Robotic System Reconditioned 120V | Sensei® | HANSEN MEDICAL, INC. |
32 | 00815671020215 | MAE95 | MAE95 | Magellan Robotic Catheter eKit Accessory Kit 95cm | Magellan™ | HANSEN MEDICAL, INC. |
33 | 00815671020208 | MAE60 | MAE60 | Magellan Robotic Catheter eKit Accessory Kit 60cm | Magellan™ | HANSEN MEDICAL, INC. |
34 | 00815671020147 | MA6F95 | MA6F95 | Magellan Robotic Catheter 6Fr Accessory Kit 95cm | Magellan™ | HANSEN MEDICAL, INC. |
35 | 00815671020130 | MA6F60 | MA6F60 | Magellan Robotic Catheter 6Fr Accessory Kit 60cm | Magellan™ | HANSEN MEDICAL, INC. |
36 | 00815671020079 | MRCCAD | MRCCAD | Magellan Robotic Catheter 9Fr & 10Fr Caddy | Magellan™ | HANSEN MEDICAL, INC. |
37 | 00815671020062 | MACC80 | MACC80 | Magellan Robotic Catheter 9Fr & 10Fr Accessory Kit 80cm | Magellan™ | HANSEN MEDICAL, INC. |
38 | 00815671020055 | MACC65 | MACC65 | Magellan Robotic Catheter 9Fr & 10Fr Accessory Kit 65cm | Magellan™ | HANSEN MEDICAL, INC. |
39 | 00815671020048 | MACC50 | MACC50 | Magellan Robotic Catheter 9Fr & 10Fr Accessory Kit 50cm | Magellan™ | HANSEN MEDICAL, INC. |