Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K003371 |
Device Name |
PUMP TUBING WITH X-COATING |
Applicant |
TERUMO CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Applicant Contact |
GARRY A COURTNEY |
Correspondent |
TERUMO CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent Contact |
GARRY A COURTNEY |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 10/30/2000 |
Decision Date | 12/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|