K232573
- 510(k) number
- K232573
- Device name
- INFINITI Ambi Angiographic Catheter
- Applicant
- Cordis US Corp FL · US
- Product code
- DQO — Catheter, Intravascular, Diagnostic
- Decision date
- 2023-11-21
- Date received
- 2023-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232573.pdf
Official FDA record: K232573
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.