Device Listing 1524100552
Listing Summary#
- Listing key
- 1524100552
- Premarket submission
- K254089
- Device
- 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
- DQK
- Decision date
- 2026-02-17