Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K200094 |
Device Name |
speX LP Support Catheter |
Applicant |
Reflow Medical |
208 Avenida Fabricante #100 |
San Clemente,
CA
92672
|
|
Applicant Contact |
Krystal Santiago |
Correspondent |
Reflow Medical |
208 Avenida Fabricante #100 |
San Clemente,
CA
92672
|
|
Correspondent Contact |
Krystal Santiago |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 01/16/2020 |
Decision Date | 03/18/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|