Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K012538 |
Device Name |
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE |
Applicant |
MEDTRONIC VASCULAR |
7611 NORTHLAND DR. |
MINNEAPOLIS,
MN
55428
|
|
Applicant Contact |
MARIE HOLM |
Correspondent |
MEDTRONIC VASCULAR |
7611 NORTHLAND DR. |
MINNEAPOLIS,
MN
55428
|
|
Correspondent Contact |
MARIE HOLM |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 08/07/2001 |
Decision Date | 08/23/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|