Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K971990 |
Device Name |
GESCO PER-Q-CATH PICC CATHETERS |
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 | 880.5200
|
Classification Product Code |
|
Date Received | 05/09/1997 |
Decision Date | 11/07/1997 |
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
|
|
|