Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K974764 |
Device Name |
INTROSYTE CATHETER |
Applicant |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
9450 SOUTH STATE ST. |
SANDY,
UT
84070
|
|
Applicant Contact |
C J WELLE |
Correspondent |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
9450 SOUTH STATE ST. |
SANDY,
UT
84070
|
|
Correspondent Contact |
C J WELLE |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 12/19/1997 |
Decision Date | 02/26/1998 |
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
|
Recalls |
CDRH Recalls
|
|
|