Device Classification Name |
probe, blood-flow, extravascular
|
510(k) Number |
K132730 |
Device Name |
BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE |
Applicant |
MEDTRONIC INC. |
7611 NORTHLAND DRIVE |
MINNEAPOLIS,
MN
55428
|
|
Applicant Contact |
JESSICA SIXBERRY |
Correspondent |
MEDTRONIC INC. |
7611 NORTHLAND DRIVE |
MINNEAPOLIS,
MN
55428
|
|
Correspondent Contact |
JESSICA SIXBERRY |
Regulation Number | 870.2120
|
Classification Product Code |
|
Date Received | 09/03/2013 |
Decision Date | 05/30/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|