K241243
- 510(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. OH · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2024-07-24
- Date received
- 2024-05-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K241243.pdf
Official FDA record: K241243
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.