K243436
- 510(k) number
- K243436
- Device name
- Seclusion Catheter
- Applicant
- Basis Medical GA · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-02-28
- Date received
- 2024-11-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K243436.pdf
Official FDA record: K243436
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.