Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K120722 |
Device Name |
RIVAL PTA DILATATION CATHETER |
Applicant |
BARD PERIPHERAL VASCULAR, INC. |
1415 WEST 3RD ST. |
TEMPE,
AZ
85281
|
|
Applicant Contact |
MARK JOB |
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 | 03/09/2012 |
Decision Date | 04/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|