Device Classification Name |
catheter, intravascular, therapeutic, long-term greater than 30 days
|
510(k) Number |
K091670 |
Device Name |
BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER |
Applicant |
BECTON DICKINSON & CO. |
9450 SOUTH STATE STREET |
SANDY,
UT
84070
|
|
Applicant Contact |
JUSTICE ALDER |
Correspondent |
BECTON DICKINSON & CO. |
9450 SOUTH STATE STREET |
SANDY,
UT
84070
|
|
Correspondent Contact |
JUSTICE ALDER |
Regulation Number | 880.5970
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/09/2009 |
Decision Date | 07/01/2009 |
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
|
|
|