K242420
- 510(k) number
- K242420
- Device name
- pNOVUS 21 Microcatheter
- Applicant
- Phenox, Ltd. IE
- Product code
- DQO — Catheter, Intravascular, Diagnostic
- Decision date
- 2024-11-12
- Date received
- 2024-08-15
- 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: K242420.pdf
Official FDA record: K242420
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.