Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K222848
Device Classification Name
More FDA Info for this Device
510(K) Number
K222848
Device Name
pRESET Thrombectomy Device
Applicant
phenox Limited
Kamrick Court, Ballybrit Business Park,
Galway H91XY38 IE
Other 510(k) Applications for this Company
Contact
Catriona Lynch
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
POL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/21/2022
Decision Date
01/20/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact