K233783

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts

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.