K240829
- 510(k) number
- K240829
- Device name
- AuST Steerable Sheath
- Applicant
- CenterPoint Systems, LLC UT · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-05-01
- Date received
- 2024-03-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K240829.pdf
Official FDA record: K240829
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.