Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K223101 |
Device Name |
BD Secondary Infusion Set |
Applicant |
CareFusion |
10020 Pacific Mesa Blvd |
San Diego,
CA
92121
|
|
Applicant Contact |
Paulina Davis |
Correspondent |
CareFusion |
10020 Pacific Mesa Blvd |
San Diego,
CA
92121
|
|
Correspondent Contact |
Paulina Davis |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 09/30/2022 |
Decision Date | 05/12/2023 |
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
|
|
|