Device Classification Name |
Dilator, Vessel, For Percutaneous Catheterization
|
510(k) Number |
K120349 |
Device Name |
SONIXGPS VASCULAR ACCESS NEEDLE KIT |
Applicant |
ULTRASONIX MEDICAL CORPATION |
130-4311 VIKING WAY |
RICHOND, BC,
CA
V6V 2K9
|
|
Applicant Contact |
CHAS YU |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
WILLIAM SAMMONS |
Regulation Number | 870.1310
|
Classification Product Code |
|
Date Received | 02/06/2012 |
Decision Date | 04/09/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|