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IOPS Visionary System - IOPS Viewpoint Simple Curve Catheter, 75cm (C00751)
FDA 510(k)Class II (US FDA 510(k))
510(k) K254089
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 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 - IOPS Viewpoint Simple Curve Catheter, 75cm (C00751) by Centerline Biomedical, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 8…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K254089 | Class II | Active |
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Manufacturer
- Manufacturer
- Centerline Biomedical, Inc.
Sources (1)
- FDA 510(k) K254089 24 fields · synced Jun 18, 2026