Device Classification Name |
catheter, peripheral, atherectomy
|
510(k) Number |
K120242 |
Device Name |
JETSTREAM NAVITUS L SYSTEM |
Applicant |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE |
KIRKLAND,
WA
98033
|
|
Applicant Contact |
BRIT BAIRD |
Correspondent |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE |
KIRKLAND,
WA
98033
|
|
Correspondent Contact |
BRIT BAIRD |
Regulation Number | 870.4875
|
Classification Product Code |
|
Date Received | 01/27/2012 |
Decision Date | 02/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Clinical Trials |
NCT00676494
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|