K233975
- 510(k) number
- K233975
- Device name
- Zoom 6F Insert Catheters
- Applicant
- Imperative Care, Inc. CA · US
- Product code
- DQO — Catheter, Intravascular, Diagnostic
- Decision date
- 2024-04-02
- Date received
- 2023-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K233975.pdf
Official FDA record: K233975
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.