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Iops™

FDA UDI

Class II (US FDA UDI)

by Centerline Biomedical

Identity

Trade Name
IOPS™ FDA UDI
Generic Name
Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
ATW-2 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
ATW-2 FDA UDI
Primary DI / UDI-DI
00843152102037 FDA UDI
510(k) Number
K190106 FDA UDI
K230309 FDA UDI
K241243 FDA UDI
K242133 FDA UDI
K243842 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Cardiac/peripheral vascular guidewire, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cardiac/peripheral vascular guidewire, single-use

Iops™ by Centerline Biomedical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac/peripheral vascular guidewire, single-use.

Cleared under the same submission

K190106 also covers:

K230309 also covers:

K241243 also covers:

K242133 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Centerline Biomedical

Sources (1)

  • FDA UDI 36c82a63-f3fc-4488-80b3-ee97d05bf9cc 36 fields · synced May 30, 2026