Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K090849 |
Device Name |
MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 |
Applicant |
EV3 INC. |
9600 54TH AVE NORTH |
PLYMOUTH,
MN
55442
|
|
Applicant Contact |
SARA BAKKAR |
Correspondent |
EV3 INC. |
9600 54TH AVE NORTH |
PLYMOUTH,
MN
55442
|
|
Correspondent Contact |
SARA BAKKAR |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 03/30/2009 |
Decision Date | 05/01/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|