Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K000776 |
Device Name |
MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP |
Applicant |
MEDTRONIC CARDIAC SURGICAL PRODUCTS |
620 WATSON S.W. |
GRAND RAPIDS,
MI
49504
|
|
Applicant Contact |
JAMES BALUN |
Correspondent |
MEDTRONIC CARDIAC SURGICAL PRODUCTS |
620 WATSON S.W. |
GRAND RAPIDS,
MI
49504
|
|
Correspondent Contact |
JAMES BALUN |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 03/10/2000 |
Decision Date | 02/07/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|