Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K060341 |
Device Name |
SHERLOCK TIP LOCATION SYSTEM (TLS) |
Applicant |
C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
LYNN M KIRCHOFF |
Correspondent |
C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
LYNN M KIRCHOFF |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 02/10/2006 |
Decision Date | 04/14/2006 |
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
|
|
|