Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K120381 |
Device Name |
Q50 PLUS STENT GRAFT BALLOON CATHETER |
Applicant |
QXMEDICAL, LLC |
1747 SUMMIT AVENUE |
ST. PAUL,
MN
55105
|
|
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/07/2012 |
Decision Date | 02/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|