K241388
- 510(k) number
- K241388
- Device name
- Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular CA · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2025-01-02
- Date received
- 2024-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241388.pdf
Official FDA record: K241388
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.