Device Classification Name |
introducer, catheter
|
510(k) Number |
K002054 |
Device Name |
X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 |
Applicant |
APPRIVA MEDICAL, INC. |
777 NORTH PASTORIA AVE. |
SUNNYVALE,
CA
94086
|
|
Applicant Contact |
MICHAEL KOLBER |
Correspondent |
APPRIVA MEDICAL, INC. |
777 NORTH PASTORIA AVE. |
SUNNYVALE,
CA
94086
|
|
Correspondent Contact |
MICHAEL KOLBER |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 07/06/2000 |
Decision Date | 02/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|