Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K926139 |
FOIA Releasable 510(k) |
K926139
|
Device Name |
CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH |
Applicant |
BARD ACCESS SYSTEMS, INC. |
5425 WEST AMELIA EARNHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
JANE ANN MARTIN |
Correspondent |
BARD ACCESS SYSTEMS, INC. |
5425 WEST AMELIA EARNHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
JANE ANN MARTIN |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 12/07/1992 |
Decision Date | 01/03/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|