K250558
- 510(k) number
- K250558
- Device name
- SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
- Applicant
- Medtronic, Inc. MN · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-03-27
- Date received
- 2025-02-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250558.pdf
Official FDA record: K250558
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.