K232321
- 510(k) number
- K232321
- Device name
- FlexCath Contour Steerable Sheath
- Applicant
- Medtronic, Inc. MN · US
- Product code
- DRA — Catheter, Steerable
- Decision date
- 2023-10-31
- Date received
- 2023-08-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K232321.pdf
Official FDA record: K232321
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.