Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K170599 |
Device Name |
SureFlo EVD Catheter |
Applicant |
Arkis BioSciences Inc. |
1059 N. Cedar BluffRD #157 |
Knoxville,
TN
37923
|
|
Applicant Contact |
Joseph Howell |
Correspondent |
Arkis BioSciences Inc. |
1059 N. Cedar BluffRD #157 |
Knoxville,
TN
37923
|
|
Correspondent Contact |
Joseph Howell |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 03/01/2017 |
Decision Date | 08/31/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|