IOPS™ ATW-2
GUDID 10843152102034
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.
Cardiac/peripheral vascular guidewire, single-use| Primary Device ID | 10843152102034 |
| NIH Device Record Key | 36c82a63-f3fc-4488-80b3-ee97d05bf9cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IOPS™ |
| Version Model Number | ATW-2 |
| Catalog Number | ATW-2 |
| Company DUNS | 080088507 |
| Company Name | CENTERLINE BIOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843152102037 [Primary] |
| GS1 | 10843152102034 [Package] Contains: 00843152102037 Package: Box [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190106
FDA Product Code
| DQK | Computer, Diagnostic, Programmable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-04-17 |
| Device Publish Date | 2020-09-18 |
On-Brand Devices [IOPS™]
| 10843152102010 | IOPS™ Guidewire 2 Handle for connection of guidewire sensor to system |
| 10843152101037 | IOPS™ Catheter Reverse Curve 1 |
| 10843152101020 | IOPS™ Catheter Simple Curve 1 |
| 10843152103000 | IOPS™ Tracking Pad 1 |
| 10843152102034 | Indications for Use: The IOPS (Intra-Operative Positioning System) is intended for the evaluatio |
Trademark Results [IOPS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IOPS 90792256 not registered Live/Pending |
CENTERLINE BIIOMEDICAL, INC. 2021-06-24 |
 IOPS 90576268 not registered Live/Pending |
The Integration Group of Americas Inc. 2021-03-12 |
 IOPS 90290764 not registered Live/Pending |
K1 Investment Management, LLC 2020-10-30 |
 IOPS 88331764 not registered Live/Pending |
CENTERLINE BIOMEDICAL, INC. 2019-03-08 |
 IOPS 87271055 5425403 Live/Registered |
John Bean Technologies Corporation 2016-12-16 |
 IOPS 74065026 1670621 Dead/Cancelled |
Policy Management Systems Corporation 1990-06-04 |
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