K233201

MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)

510(k) number
K233201
Device name
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)
Applicant
Penumbra, Inc. CA · US
Product code
QJP — Catheter, Percutaneous, Neurovasculature
Decision date
2024-03-27
Date received
2023-09-28
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K233201.pdf

Official FDA record: K233201
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.