Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K113700 |
Device Name |
VIAVALVE SAFETY IV CATHETER |
Applicant |
SMITHS MEDICAL ASD, INC. |
201 WEST QUEEN ST. |
SOUTHINGTON,
CT
06489
|
|
Applicant Contact |
BRIAN FARIAS |
Correspondent |
SMITHS MEDICAL ASD, INC. |
201 WEST QUEEN ST. |
SOUTHINGTON,
CT
06489
|
|
Correspondent Contact |
BRIAN FARIAS |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 12/16/2011 |
Decision Date | 03/14/2012 |
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
|
|
|