Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K003085 |
Device Name |
CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 |
Applicant |
CONCENTRIC MEDICAL, INC. |
2585 LEGHORN ST. |
MOUTIAN VIEW,
CA
94043
|
|
Applicant Contact |
LINDA BRADLEY |
Correspondent |
CONCENTRIC MEDICAL, INC. |
2585 LEGHORN ST. |
MOUTIAN VIEW,
CA
94043
|
|
Correspondent Contact |
LINDA BRADLEY |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 10/03/2000 |
Decision Date | 03/07/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|