Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K112404 |
Device Name |
CONCENTRIC BALLOON GUIDE CATHETER |
Applicant |
CONCENTRIC MEDICAL, INC. |
301 E. EVELYN AVE. |
MOUNTAIN VIEW,
CA
94041
|
|
Applicant Contact |
KIRSTEN VALLEY |
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 |
|
Date Received | 08/22/2011 |
Decision Date | 03/15/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|