K233551
- 510(k) number
- K233551
- Device name
- GORE® ACUSEAL Vascular Graft
- Applicant
- W. L. Gore & Associates, Inc. AZ · US
- Product code
- DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diame
- Decision date
- 2023-12-19
- Date received
- 2023-11-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K233551.pdf
Official FDA record: K233551
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.