Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K233448 |
Device Name |
Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set |
Applicant |
Integra LifeSciences Production Corporation |
11 Cabot Boulevard |
Mansfield,
MA
02048
|
|
Applicant Contact |
Amanda Erwin |
Correspondent |
Integra LifeSciences Production Corporation |
11 Cabot Boulevard |
Mansfield,
MA
02048
|
|
Correspondent Contact |
Jocelyn Raposo |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 10/20/2023 |
Decision Date | 12/19/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|