Device Classification Name |
catheter, peripheral, atherectomy
|
510(k) Number |
K120346 |
Device Name |
CLEANER ROTATIONAL THROMBECTOMY SYSTEM |
Applicant |
REX MEDICAL |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
REX MEDICAL |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 870.4875
|
Classification Product Code |
|
Date Received | 02/03/2012 |
Decision Date | 06/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|