IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter,
Summary
Centerline Biomedical, Inc. received 510(k) clearance for 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 DQK device. Cleared on 2026-02-17.
Details
Source
510(k) Clearance
External ID
K254089
Action Date
2026-02-17
Status
Traditional
Category
device
Product Code
DQK
Product Description
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). Product code: DQK.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Centerline Biomedical, Inc. has received 5 total clearances in our database.
Centerline Biomedical, Inc. has 6 FDA actions in our database, including 1 recall and 5 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Centerline Biomedical, Inc. have FDA actions?
Centerline Biomedical, Inc. has 6 FDA actions in our database, including 1 recall and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K254089" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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