K242133
- 510(k) number
- K242133
- Device name
- Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)
- Applicant
- Centerline Biomedical, Inc. OH · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2024-10-11
- Date received
- 2024-07-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242133.pdf
Official FDA record: K242133
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.