Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K190393 |
Device Name |
Wingman 14C Crossing Catheter |
Applicant |
ReFlow Medical, Inc. |
208 Avenida Fabricante #100 |
San Clemente,
CA
92672
|
|
Applicant Contact |
Rebecca K Pine |
Correspondent |
ReFlow Medical, Inc. |
208 Avenida Fabricante #100 |
San Clemente,
CA
92672
|
|
Correspondent Contact |
Rebecca K Pine |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 02/19/2019 |
Decision Date | 05/09/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|