K243948
- 510(k) number
- K243948
- Device name
- Raptor Aspiration Catheter; Balt Aspiration Tubing Set
- Applicant
- Balt USA, LLC CA · US
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2025-06-03
- Date received
- 2024-12-23
- 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: K243948.pdf
Official FDA record: K243948
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.