Device Classification Name |
Catheter, Peripheral, Atherectomy
|
510(k) Number |
K161361 |
Device Name |
HawkOne Directional Atherectomy System |
Applicant |
Medtronic Vascular, Inc. |
(formerly d.b.a ev3 Inc., Covidien llc) |
3033 Campus Drive |
Plymouth,
MN
55441
|
|
Applicant Contact |
Rupali Gupta |
Correspondent |
Medtronic Vascular, Inc. |
(formerly d.b.a ev3 Inc., Covidien llc) |
3033 Campus Drive |
Plymouth,
MN
55441
|
|
Correspondent Contact |
Rupali Gupta |
Regulation Number | 870.4875
|
Classification Product Code |
|
Date Received | 05/16/2016 |
Decision Date | 10/14/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|