Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)
FDA 510(k) clearance K241243 · decided 2024-07-24
Clearance details
- K-number
- K241243
- Device name
- Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)
- Applicant
- Centerline Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-05-03
- Decision date
- 2024-07-24
- Days to decision
- 82 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 |