Device Classification Name |
Catheter, Continuous Flush
|
510(k) Number |
K000177 |
Device Name |
RENEGADE HI-FLO MICROCATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick,
MA
01760
|
|
Applicant Contact |
TERRY A MCGOVERN |
Correspondent |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick,
MA
01760
|
|
Correspondent Contact |
TERRY A MCGOVERN |
Regulation Number | 870.1210
|
Classification Product Code |
|
Date Received | 01/20/2000 |
Decision Date | 04/07/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|