Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K111236 |
Device Name |
INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 |
Applicant |
B. BRAUN MELSUNGEN AG |
901 MARCON BLVD |
ALLENTOWN,
PA
18109
|
|
Applicant Contact |
ANGELA J CARAVELLA |
Correspondent |
B. BRAUN MELSUNGEN AG |
901 MARCON BLVD |
ALLENTOWN,
PA
18109
|
|
Correspondent Contact |
ANGELA J CARAVELLA |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 05/02/2011 |
Decision Date | 08/30/2011 |
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
|
|
|