Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K924642 |
Device Name |
MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER |
Applicant |
MEDTRONIC BIO-MEDICUS, INC. |
9600 WEST 76TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
THOMAS K JOHNSEN |
Correspondent |
MEDTRONIC BIO-MEDICUS, INC. |
9600 WEST 76TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
THOMAS K JOHNSEN |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 09/14/1992 |
Decision Date | 03/26/1993 |
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
|
|
|