Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K202800 |
Device Name |
Pacific Plus PTA Catheter |
Applicant |
Medtronic Vascular,Inc(formerly d.b.a ev3 Inc.,Covidien llc) |
3033 Campus Drive |
Maple Grove,
MN
55441
|
|
Applicant Contact |
Rupali Gupta |
Correspondent |
Medtronic Vascular,Inc(formerly d.b.a ev3 Inc.,Covidien llc) |
3033 Campus Drive |
Maple Grove,
MN
55441
|
|
Correspondent Contact |
Rupali Gupta |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 09/23/2020 |
Decision Date | 11/18/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|