Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)
FDA 510(k) clearance K230309 · decided 2023-06-21
Clearance details
- K-number
- K230309
- Device name
- Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)
- Applicant
- Centerline Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-02-03
- Decision date
- 2023-06-21
- Days to decision
- 138 days
- Clearance type
- Special
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate throug recall (Z-1760-2025) | Centerline Biomedical Inc | 2025-05-19 |