Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K220584 |
Device Name |
BD Cathena Safety IV Catheter |
Applicant |
Becton Dickinson Infusion Therapy Systems Inc. |
9450 South State Street |
Sandy,
UT
84070
|
|
Applicant Contact |
Paul Holman |
Correspondent |
Becton Dickinson Infusion Therapy Systems Inc. |
9450 South State Street |
Sandy,
UT
84070
|
|
Correspondent Contact |
Paul Holman |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 03/01/2022 |
Decision Date | 03/31/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|