Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K141547 |
Device Name |
WINGMAN EXTENDABLE TIP SUPPORT CATHETER |
Applicant |
REFLOW MEDICAL |
1003 Calle Sombra |
San Clemente,
CA
92673
|
|
Applicant Contact |
Rebecca K Pine |
Correspondent |
REFLOW MEDICAL |
1003 Calle Sombra |
San Clemente,
CA
92673
|
|
Correspondent Contact |
Rebecca K Pine |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 06/11/2014 |
Decision Date | 09/30/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|