K233924

EMBOGUARD Balloon Guide Catheter

510(k) number
K233924
Device name
EMBOGUARD Balloon Guide Catheter
Applicant
Neuravi Limited IE
Product code
QJP — Catheter, Percutaneous, Neurovasculature
Decision date
2024-04-18
Date received
2023-12-13
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K233924.pdf

Official FDA record: K233924
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.