Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K091304 |
Device Name |
VORTEX CANNULA |
Applicant |
VORTEX MEDICAL INC |
50 LORING DRIVE |
NORWELL,
MA
02061
|
|
Applicant Contact |
CHERYL BLAKE |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
455 E. TRIMBLE ROAD |
SAN JOSE,
CA
95131 -1230
|
|
Correspondent Contact |
MORTEN CHRISTENSEN |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 05/04/2009 |
Decision Date | 07/02/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|