Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K120863 |
Device Name |
WHOLEY GUIDE WIRE SYSTEM |
Applicant |
Covidien LLC |
3033 Campus Drive |
Plymouth,
MN
55441
|
|
Applicant Contact |
DAVID RBERTSON |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 03/22/2012 |
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
|
|
|