Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K151244 |
Device Name |
Pre-Formed Guidewire |
Applicant |
Lake Region Medical |
340 Lake Hazeltine Dr. |
Chaska,
MN
55318
|
|
Applicant Contact |
Mathew Pexa |
Correspondent |
Lake Region Medical |
340 Lake Hazeltine Dr. |
Chaska,
MN
55318
|
|
Correspondent Contact |
Mathew Pexa |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 05/11/2015 |
Decision Date | 06/11/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|