Device Classification Name |
Aspiration Thrombectomy Catheter
|
510(k) Number |
K051917 |
Device Name |
DIVER C.E. CATHETER |
Applicant |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
4600 Nathan Lane North |
Plymouth,
MN
55442
|
|
Applicant Contact |
STEPHANIE K ISGRIGG ROBINSON |
Correspondent |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
4600 Nathan Lane North |
Plymouth,
MN
55442
|
|
Correspondent Contact |
STEPHANIE K ISGRIGG ROBINSON |
Regulation Number | 870.5150
|
Classification Product Code |
|
Date Received | 07/15/2005 |
Decision Date | 08/08/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|