Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K021899 |
Device Name |
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 |
Applicant |
CONCENTRIC MEDICAL, INC. |
2585 LEGHORN ST. |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
KEVIN MACDONALD |
Correspondent |
CONCENTRIC MEDICAL, INC. |
2585 LEGHORN ST. |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
KEVIN MACDONALD |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 06/10/2002 |
Decision Date | 07/10/2002 |
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
|
|
|