K234083
- 510(k) number
- K234083
- Device name
- Next Generation Aspiration Catheter; Balt Aspiration Tubing Set
- Applicant
- Balt USA, LLC CA · US
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2024-07-02
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K234083.pdf
Official FDA record: K234083
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.