Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K201811 |
Device Name |
coraForce and coraFlex Support Catheters |
Applicant |
Reflow Medical, Inc. |
208 Avenida Fabricante #100 |
San Clemente,
CA
92672
|
|
Applicant Contact |
Krystal Santiago |
Correspondent |
Reflow Medical, Inc. |
208 Avenida Fabricante #100 |
San Clemente,
CA
92672
|
|
Correspondent Contact |
Krystal Santiago |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/01/2020 |
Decision Date | 10/26/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|