Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K221575 |
Device Name |
Pre-Formed Blue |
Applicant |
Lake Region Medical |
340 Lake Hazeltine Drive |
Chaska,
MN
55318
|
|
Applicant Contact |
Deko Hussein |
Correspondent |
Lake Region Medical |
340 Lake Hazeltine Drive |
Chaska,
MN
55318
|
|
Correspondent Contact |
Deko Hussein |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 06/01/2022 |
Decision Date | 10/07/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|