Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K133856 |
Device Name |
POWERGLIDE MIDLINE CATHETER |
Applicant |
C.R. BARD, INC. |
605 NORTH 5600 WEST |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
CASEY COOMBS |
Correspondent |
C.R. BARD, INC. |
605 NORTH 5600 WEST |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
CASEY COOMBS |
Regulation Number | 880.5200 |
Classification Product Code |
|
Date Received | 12/19/2013 |
Decision Date | 01/16/2014 |
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
|
Predetermined Change Control Plan Authorized |
No
|
Recalls |
CDRH Recalls
|
|
|