Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K010954 |
Device Name |
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031 |
Applicant |
CONCENTRIC MEDICAL, INC. |
2585 LEGHORN ST. |
MOUTIAN VIEW,
CA
94043
|
|
Applicant Contact |
KEVIN MACDONALD |
Correspondent |
CONCENTRIC MEDICAL, INC. |
2585 LEGHORN ST. |
MOUTIAN VIEW,
CA
94043
|
|
Correspondent Contact |
KEVIN MACDONALD |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 03/30/2001 |
Decision Date | 10/09/2001 |
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
|
|
|