Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K082579 |
Device Name |
EVERCROSS .035 OTW PTA DILATATION CATHETER |
Applicant |
EV3 INC. |
4600 NATHAN LN. NORTH |
PLYMOUTH,
MN
55442 -2920
|
|
Applicant Contact |
David Worrell |
Correspondent |
EV3 INC. |
4600 NATHAN LN. NORTH |
PLYMOUTH,
MN
55442 -2920
|
|
Correspondent Contact |
David Worrell |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 09/05/2008 |
Decision Date | 11/20/2008 |
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
|
|
|