Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K113565 |
Device Name |
MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN |
Applicant |
EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY |
IRVINE,
CA
92614
|
|
Applicant Contact |
MARGUEITE THOMLINSON |
Correspondent |
EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY |
IRVINE,
CA
92614
|
|
Correspondent Contact |
MARGUEITE THOMLINSON |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 12/02/2011 |
Decision Date | 05/18/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|