K231227
- 510(k) number
- K231227
- Device name
- SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
- Applicant
- Baylis Medical Company, Inc. CA
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2023-12-20
- Date received
- 2023-04-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K231227.pdf
Official FDA record: K231227
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.