Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K003410 |
Device Name |
CONCENTRIC RETRIEVER, MODEL 90030 |
Applicant |
CONCENTRIC MEDICAL, INC. |
2585 LEGHORN ST. |
MOUTIAN VIEW,
CA
94043
|
|
Applicant Contact |
SAM LAZZARA |
Correspondent |
CONCENTRIC MEDICAL, INC. |
2585 LEGHORN ST. |
MOUTIAN VIEW,
CA
94043
|
|
Correspondent Contact |
SAM LAZZARA |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 11/02/2000 |
Decision Date | 05/22/2001 |
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
|
|
|