Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K090878 |
Device Name |
MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING) |
Applicant |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103
|
|
Applicant Contact |
CHRISTINA THOMAS |
Correspondent |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103
|
|
Correspondent Contact |
CHRISTINA THOMAS |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 03/31/2009 |
Decision Date | 04/03/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|