Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K034061 |
Device Name |
MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH |
Applicant |
BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
CHRISTINA L ROWE |
Correspondent |
BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. |
SAN JOSE,
CA
95134
|
|
Correspondent Contact |
CHRISTINA L ROWE |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 12/31/2003 |
Decision Date | 01/30/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|