Device Classification Name |
catheter, peripheral, atherectomy
|
510(k) Number |
K191419 |
Device Name |
Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire |
Applicant |
Rex Medical, L.P. |
555 East North Lane, Suite 5035 |
Conshohocken,
PA
19428
|
|
Applicant Contact |
Colin Valentis |
Correspondent |
Rex Medical, L.P. |
555 East North Lane, Suite 5035 |
Conshohocken,
PA
19428
|
|
Correspondent Contact |
Colin Valentis |
Regulation Number | 870.4875
|
Classification Product Code |
|
Date Received | 05/28/2019 |
Decision Date | 09/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02961894
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|