K253409
- 510(k) number
- K253409
- Device name
- C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
- Applicant
- Medtronic, Inc. MN · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-12-19
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253409.pdf
Official FDA record: K253409
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.