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IOPS Visionary System (MC-3) +7 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K254089

by Centerline Biomedical, Inc.

Identifiers

510(k) Number
K254089 FDA 510(k)
FDA Product Code
DQK FDA 510(k)
Models / Variants
IOPS Visionary System (MC-3) FDA 510(k)
IOPS Viewpoint Simple Curve Catheter, 75cm (C00751) FDA 510(k)
IOPS Viewpoint Simple Curve Catheter, 125cm (C01251) FDA 510(k)
IOPS Viewpoint Double Curve Catheter, 75cm (C00752) FDA 510(k)
IOPS Viewpoint Double Curve Catheter, 125cm (C02152) FDA 510(k)
IOPS Guidewire 2 (ATW-2) FDA 510(k)
IOPS Fiducial Tracking Pad (T02111) FDA 510(k)
IOPS Guidewire Handle (H01035) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1425 FDA 510(k)
Regulation Number
870.1425 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

IOPS Visionary System (MC-3) +7 more models by Centerline Biomedical, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 8 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Centerline Biomedical, Inc.

Sources (1)

  • FDA 510(k) K254089 24 fields · synced Jun 18, 2026