Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K213664 |
Device Name |
B. Braun Introcan Safety 2 IV Catheter |
Applicant |
B. Braun Medical Inc. |
901 Marcon Blvd. |
Allentown,
PA
18109
|
|
Applicant Contact |
Tracy Larish |
Correspondent |
B. Braun Medical Inc. |
901 Marcon Blvd. |
Allentown,
PA
18109
|
|
Correspondent Contact |
Tracy Larish |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 11/22/2021 |
Decision Date | 02/11/2022 |
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
|
|
|