Device Classification Name |
catheter, ultrasound, intravascular
|
510(k) Number |
K103255 |
Device Name |
VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET |
Applicant |
VASONOVA INC. |
155 JEFFERSON DRIVE |
SUITE 100 |
MENLO PARK,
CA
94025
|
|
Applicant Contact |
KIM TOMPKINS, RN, MBA |
Correspondent |
VASONOVA INC. |
155 JEFFERSON DRIVE |
SUITE 100 |
MENLO PARK,
CA
94025
|
|
Correspondent Contact |
KIM TOMPKINS, RN, MBA |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 11/03/2010 |
Decision Date | 02/18/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01232933
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|