Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K203609 |
Device Name |
Intravascular Administration Sets |
Applicant |
Baxter Healthcare Corporation |
25212 West Illinois Route 120 |
Round Lake,
IL
60073
|
|
Applicant Contact |
Jeffrey E. Thompson |
Correspondent |
Baxter Healthcare Corporation |
25212 West Illinois Route 120 |
Round Lake,
IL
60073
|
|
Correspondent Contact |
Jeffrey E. Thompson |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/10/2020 |
Decision Date | 09/30/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|