Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K023937 |
Device Name |
COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM |
Applicant |
COOK VASCULAR, INC. |
RT. 66, RIVER RD. |
P.O. BOX 529 |
LEECHBURG,
PA
15656 -0529
|
|
Applicant Contact |
THOMAS J KARDOS |
Correspondent |
COOK VASCULAR, INC. |
RT. 66, RIVER RD. |
P.O. BOX 529 |
LEECHBURG,
PA
15656 -0529
|
|
Correspondent Contact |
THOMAS J KARDOS |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 11/26/2002 |
Decision Date | 05/27/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|