Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K062809 |
Device Name |
ADMIRAL XTREME PTA CATHETER |
Applicant |
INVATEC INNOVATIVE TECHNOLOGIES |
9600 54TH AVENUE NORTH |
PLYMOUTH,
MN
55442
|
|
Applicant Contact |
David Worrell |
Correspondent |
INVATEC INNOVATIVE TECHNOLOGIES |
9600 54TH AVENUE NORTH |
PLYMOUTH,
MN
55442
|
|
Correspondent Contact |
David Worrell |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 09/19/2006 |
Decision Date | 10/18/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|