Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K001139 |
Device Name |
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M |
Applicant |
BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. |
DIAMOND BAR,
CA
91765
|
|
Applicant Contact |
MARY ADAMS |
Correspondent |
BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. |
DIAMOND BAR,
CA
91765
|
|
Correspondent Contact |
MARY ADAMS |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 04/10/2000 |
Decision Date | 05/10/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|