Device Classification Name |
Catheter, Percutaneous, Neurovasculature
|
510(k) Number |
K214048 |
FOIA Releasable 510(k) |
K214048
|
Device Name |
Millipede 088 Access Catheter |
Applicant |
Perfuze Ltd. |
Unit 6, Galway Business Park, Dangan |
Galway,
IE
H91 W7CP
|
|
Applicant Contact |
Anne-Marie Gannon |
Correspondent |
Perfuze Ltd. |
Unit 6, Galway Business Park, Dangan |
Galway,
IE
H91 W7CP
|
|
Correspondent Contact |
Anne-Marie Gannon |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 12/27/2021 |
Decision Date | 09/20/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|