Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K092965 |
Device Name |
TRAILRUNNER GUIDEWIRES |
Applicant |
LAKE REGION MFG., INC. |
340 LAKE HAZELTINE DR. |
CHASKA,
MN
55318
|
|
Applicant Contact |
KAREN MORTENSEN |
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 | 09/25/2009 |
Decision Date | 02/26/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|