Device Classification Name |
Probe, Blood-Flow, Extravascular
|
510(k) Number |
K012747 |
Device Name |
TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P) |
Applicant |
MEDTRONIC PERFUSION SYSTEMS |
7611 NORTHLAND DR. |
MINNEAPOLIS,
MN
55038
|
|
Applicant Contact |
MARIE HOLM |
Correspondent |
MEDTRONIC PERFUSION SYSTEMS |
7611 NORTHLAND DR. |
MINNEAPOLIS,
MN
55038
|
|
Correspondent Contact |
MARIE HOLM |
Regulation Number | 870.2120
|
Classification Product Code |
|
Date Received | 08/16/2001 |
Decision Date | 09/14/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|