Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K022450 |
Device Name |
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY |
Applicant |
DIDECO S.P.A. |
195 WEST ST. |
WALTHAM,
MA
02451 -1163
|
|
Applicant Contact |
BARRY SALL |
Correspondent |
DIDECO S.P.A. |
195 WEST ST. |
WALTHAM,
MA
02451 -1163
|
|
Correspondent Contact |
BARRY SALL |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 07/26/2002 |
Decision Date | 10/22/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|