Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K180088 |
Device Name |
TrapLiner catheter |
Applicant |
Vascular Solutions, Inc. |
6464 Sycamore Court North |
Minneapolis,
MN
55369
|
|
Applicant Contact |
Beka Vite |
Correspondent |
Vascular Solutions, Inc. |
6464 Sycamore Court North |
Minneapolis,
MN
55369
|
|
Correspondent Contact |
Beka Vite |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 01/12/2018 |
Decision Date | 04/04/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|