FDA.reportPublic FDA data

CENTERLINE BIOMEDICAL

Matched from indexed company URL: Centerline Biomedical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30121542263012154226CENTERLINE BIOMEDICAL1N2026-01-014535 Renaissance Pkwy Cleveland OH US 44128

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00843152102037IOPS™ - 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.216-200-6394carroll.martin@centerlinebiomedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2335901574061498K261329
2335901524100552K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)DQK2026-02-17
2335901523532861K243842Intra-Operative Positioning System (IOPS®)DQK2025-03-06
2335901566626270K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)DQK2024-10-11
2335901270217633K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)DQK2024-07-24
2335901196614779K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)DQK2023-06-21
2335902056535713K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire HandleDQK2019-06-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQK62026-02-17

PMN#

GUDID#

IOPS Mobile Cart - 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.

2020-09-18

IOPS™ - 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.

2020-09-18

IOPS Visionary System - The IOPS® Visionary system displays the position and orientation of sensor-equipped IOPS guidewires and IOPS catheters utilizing electromagnetic tracking technology. The system enables mapping of the patient's vascular system utilizing previously-acquired scan data (CT). IOPS Visionary tracks the location and orientation of the sensors in real time, superimposing navigation of the IOPS Catheter and IOPS Guidewire to the patient's vascular map. The system consists of a surgical navigation technology and a number of associated accessories. The navigation technology is a non-contact, reusable, multi-patient use device. The associated accessories are single use devices provided sterile (EtO). The IOPS Visionary 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.

Centerline Biomedical, Inc.

2026-02-24

IOPS™ Software Application - 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.

2020-09-18

IOPS™ - 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 intervention in the descending aorta. 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.

2020-09-18