Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K092299 |
Device Name |
TRAILBLAZER SUPPORT CATHETER |
Applicant |
EV3 INC |
1394 25TH STREET NW |
BUFFALO,
MN
55113 -2920
|
|
Applicant Contact |
DAVID ROBERTSON |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/29/2009 |
Decision Date | 08/07/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|