Cleared Traditional

IOPS 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)

K254089 · Centerline Biomedical, Inc. · Cardiovascular

Feb 2026

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K254089 is an FDA 510(k) clearance for the IOPS 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), a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Centerline Biomedical, Inc. (Cleveland, US). The FDA issued a Cleared decision on February 17, 2026, 60 days after receiving the submission on December 19, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number	K254089 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2025
Decision Date	February 17, 2026
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF