K233783
- 510(k) number
- K233783
- Device name
- exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
- Applicant
- Peca Labs, Inc. PA · US
- Product code
- DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diame
- Decision date
- 2024-01-17
- Date received
- 2023-11-27
- 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: K233783.pdf
Official FDA record: K233783
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.