Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K011664 |
Device Name |
IMAGER II ANGIOGRAPHIC CATHETER |
Applicant |
BOSTON SCIENTIFIC/MEDI-TECH |
ONE BOSTON SCIENTIFIC PLACE |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
JODI L GREENIZEN |
Correspondent |
BOSTON SCIENTIFIC/MEDI-TECH |
ONE BOSTON SCIENTIFIC PLACE |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
JODI L GREENIZEN |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 05/30/2001 |
Decision Date | 09/07/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|