IOPS Visionary System (MC-3) +7 more— 510(k) K254089
Substantially EquivalentCenterline Biomedical, Inc.
FDA 510(k) clearance K254089 for IOPS Visionary System (MC-3) +7 more, Substantially Equivalent on 2026-02-17. Applicant: Centerline Biomedical, Inc.. Device class: 2.
Clearance details
- Device name as filed
- 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)
- Applicant
- Centerline Biomedical, Inc.
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cleveland, OH, US
Recent devices under product code DQK
view allMore clearances from Centerline Biomedical, Inc.
view all- K243842 — Intra-Operative Positioning System (IOPS®)
- K242133 — Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad) +1 more
- K241243 — Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters) +1 more
- K230309 — Intra-Operative Positioning System (IOPS®) (MC-1) +4 more
- K190106 — Intra-Operative Positioning System +4 more
Adverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.