Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K130858 |
Device Name |
REVERSE MEDICAL MICROCATHETER |
Applicant |
REVERSE MEDICAL CORPORATION |
13700 ALTON PARKWAY SUITE 167 |
IRVINE,
CA
92618
|
|
Applicant Contact |
JEFFREY VALKO |
Correspondent |
REVERSE MEDICAL CORPORATION |
13700 ALTON PARKWAY SUITE 167 |
IRVINE,
CA
92618
|
|
Correspondent Contact |
JEFFREY VALKO |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/28/2013 |
Decision Date | 10/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|