Device Classification Name |
catheter for crossing total occlusions
|
510(k) Number |
K221163 |
Device Name |
Tunnel Crossing Catheter |
Applicant |
Tractus Vascular, LLC |
20 Meridian Road |
Unit 9B |
Eatontown,
NJ
07724
|
|
Applicant Contact |
Janet Burpee |
Correspondent |
Tractus Vascular, LLC |
20 Meridian Road |
Unit 9B |
Eatontown,
NJ
07724
|
|
Correspondent Contact |
Janet Burpee |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 04/22/2022 |
Decision Date | 01/19/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|