K233691
- 510(k) number
- K233691
- Device name
- FlexCath Cross Transseptal Solution
- Applicant
- Acutus Medical, Inc. CA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2023-12-17
- Date received
- 2023-11-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K233691.pdf
Official FDA record: K233691
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.