K240711

Zipline Access Catheter

510(k) number
K240711
Device name
Zipline Access Catheter
Applicant
Perfuze, Ltd. IE
Product code
QJP — Catheter, Percutaneous, Neurovasculature
Decision date
2024-10-17
Date received
2024-03-15
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K240711.pdf

Official FDA record: K240711
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.