Device Classification Name |
Dislodger, Stone, Flexible
|
510(k) Number |
K001563 |
Device Name |
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET |
Applicant |
SCION CARDIOVASCULAR, INC. |
14256 SW 119 AVE. |
MIAMI,
FL
33186
|
|
Applicant Contact |
DAVID B JONES |
Correspondent |
SCION CARDIOVASCULAR, INC. |
14256 SW 119 AVE. |
MIAMI,
FL
33186
|
|
Correspondent Contact |
DAVID B JONES |
Regulation Number | 876.4680
|
Classification Product Code |
|
Date Received | 05/19/2000 |
Decision Date | 11/22/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|