Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K022272 |
Device Name |
MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) |
Applicant |
MEDTRONIC CARDIAC SURGICAL PRODUCTS |
620 WATSON ST. SW |
GRAND RAPIDS,
MI
49504 -6393
|
|
Applicant Contact |
ROGER BRINK |
Correspondent |
MEDTRONIC CARDIAC SURGICAL PRODUCTS |
620 WATSON ST. SW |
GRAND RAPIDS,
MI
49504 -6393
|
|
Correspondent Contact |
ROGER BRINK |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 07/15/2002 |
Decision Date | 01/08/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|