Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K111288 |
Device Name |
ANCHORWIRE GUIDEWIRE |
Applicant |
LAKE REGION MEDICAL |
340 LAKE HAZELTINE DRIVE |
CHASKA,
MN
55318
|
|
Applicant Contact |
MATHEW PEXA |
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 | 05/06/2011 |
Decision Date | 08/02/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|