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IOPS™ Tracking Pad 1
Centerline Biomedical, Inc.
TP-1
In Commercial Distribution
- 10843152103000 ()
- 00843152103003 ()
TP-1
- Electromagnetic surgical navigation device tracking system
Guidewire Handle
Centerline Biomedical, Inc.
H01035
In Commercial Distribution
- 10843152102058 ()
- 00843152102051 ()
H01035
- Electromagnetic surgical navigation device tracking system
Indications for Use: The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
IOPS™ Guidewire 2 is a sensorized wire used to navigate through vasculature to facilitate placement of a catheter. The guidewire is a single-use, externally communicating device that comes into contact with circulating blood for a duration of less than or equal to 24 hours.
Centerline Biomedical, Inc.
ATW-2
In Commercial Distribution
- 10843152102034 ()
- 00843152102037 ()
ATW-2
- Cardiac/peripheral vascular guidewire, single-use
IOPS™ Guidewire 2 Handle for connection of guidewire sensor to system
Centerline Biomedical, Inc.
SSH-1
In Commercial Distribution
- 10843152102010 ()
- 00843152102013 ()
SSH-1
- Cardiac/peripheral vascular guidewire, single-use
IOPS™ Catheter Reverse Curve 1
Centerline Biomedical, Inc.
RCC-1
In Commercial Distribution
- 10843152101037 ()
- 00843152101030 ()
RCC-1
- Vascular guide-catheter, single-use
IOPS™ Catheter Simple Curve 1
Centerline Biomedical, Inc.
SCC-1
In Commercial Distribution
- 10843152101020 ()
- 00843152101023 ()
SCC-1
- Vascular guide-catheter, single-use
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
MC-1
In Commercial Distribution
- 00843152100002 ()
MC-1
- Electromagnetic surgical navigation device tracking system
ELECTRODE 9670590 5BX LOCALISA
MEDTRONIC, INC.
9670590
In Commercial Distribution
- 20643169006878 ()
- 00643169006874 ()
- Cardiac mapping system reference patch
No Description
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution
- 05415067004697 ()
H700469
- Cardiac mapping system
Connect
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution
- 05415067004680 ()
H700468
- Cardiac mapping system