K234115
- 510(k) number
- K234115
- Device name
- APRO 55 Catheter
- Applicant
- Alembic, LLC CA · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2024-03-15
- Date received
- 2023-12-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K234115.pdf
Official FDA record: K234115
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.